Alaska Legislator Introduces Compounding Legislation

HB 319, Drug/Device Distributors: Compounded RX;
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Virginia law does not allow using compounded drugs for execution even if they were available-bill introduced to allow execution by electrocution

During the week:

 

Execution by electrocution bills -- (HB1052 Miller and (SB607) Carrico --  are examples of identical bills that meander successfully through several committee hearings and floor debates but receive opposite results in the opposite body.  With new information and continuing confusion about lethal drug availability SB607 was defeated in the Senate Courts of Justice Committee. HB1502, however, survived the House committees and the House Floor 64-32 sending it to the Senate for action where it was defeated in a committee and never went to the Senate floor for a vote. Currently, Virginia law does not allow using compounded drugs for execution even if they were available. Further confusion occurred with the report that the Department of Corrections has obtained a substitute drug.

quoted from here

Australia's Queensland Health Confirms compounded drugs were contaminated

Australia’s Queensland Health says that a fungal contamination occurred in a bad batch of chemotherapy drugs used to treat 17 Queensland cancer patients, ABC reported.

Queensland Health says the patients were in public and private hospitals across the state and have not suffered any adverse effects to date, but are being closely monitored by their clinicians.

The Therapeutic Goods Administration (TGA) issued a product recall notice for compounded drugs manufactured by Fresenius Kabi Australia Proprietary Limited two weeks ago.

The TGA says a risk assessment by Fresenius Kabi found there is a potential risk for patients as the sterility of product may have been compromised.

All affected stocks of the suspect drug have now been recalled.

To read more NewsPoints articles, click here.

American Health Lawyers Association: Update Federal Legislative Response to the Controversy Over Compounding

1. 
   

   UPDATE: FEDERAL LEGISLATIVE RESPONSE TO THE CONTROVERSY OVER DRUG COMPOUNDING
2. 84
3. Introduction

   87
4. The Drug Quality and Security Act

   87
   1. Potential impact

      88
   2. Critical response

      90
5. Conclusion

   91

here

NM Racing Commission Reverses Decision, Will Allow Closely-Monitored Clenbuterol Use

Friday, February 21, 2014

The New Mexico Racing Commission has decided to end its current ban on the use of clenbuterol, and will now allow it to be given in closely-monitored, “miniscule” amounts.

 

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Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--41 comments received so far

source found here

Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations-12 comments submitted so far--4 available for public to view

View All (4)

No comments posted.

	NOMINATION:COMPOUNDED HORMONE PELLETS a.k.a. BHRT Fused Pellets Implants (SottoPelle; Armor Vie; other brand names)BACKGROUND:I am a board-certified...”
	View Comment Submitter Name: Posted: 02/06/2014 ID: FDA-2013-N-1523-0003

	NOMINATION:Compounded Oral Itraconazole (Sporanox)WHY IS THIS DRUG BEING NOMINATED:Gigi Davidson, RPh, explains it better than I can, but simply put, ORAL...”
	View Comment Submitter Name: Posted: 02/06/2014 ID: FDA-2013-N-1523-0004

	NOMINATION:Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and...”
	View Comment Submitter Name: Posted: 02/06/2014 ID: FDA-2013-N-1523-0002

	See attached file(s)”
	View Comment Submitter Name: Posted: 02/06/2014 ID: FDA-2013-N-1523-0005

Public Hearing Scheduled for February 25, 2014 on compounding legislation in Connecticut

An Act Concerning the Pharmacy Practice Act and Counterfeit Drugs bill which is HB 5262, can be reviewed by clicking here. A group of Connecticut compounding pharmacists met at CPA offices this week to further discuss the proposed and submit comments to the Department of Consumer Protection. A public hearing on this is scheduled for this Tuesday, February 25, 2014

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Upton Touts Committee’s Landmark Drug Quality and Security Law During Visit to Michigan Drug Manufacturer February 21, 2014 -

Upton: “Across the nation, Americans going to the doctor’s office or pharmacy will now have the confidence that their drugs are safe.” 

House Energy and Commerce Committee Chairman Fred Upton (R-MI) visited Allegan, Michigan, drug manufacturer Perrigo Company this week to celebrate the enactment of the H.R. 3204, the Drug Quality and Security Act. The Drug Quality and Security Act was the product of a bipartisan, bicameral breakthrough led by Chairman Upton following the committee’s yearlong investigation of the fungal meningitis outbreak. The bill protects traditional pharmacies and clarifies laws related to human drug compounding while also strengthening the prescription drug supply chain in order to defend American families against counterfeit drugs and to protect jobs. Perrigo is one of the world’s largest generic drug manufacturers and employs approximately 3,500 people in West Michigan. As Upton explained during his visit to Perrigo, “Not only does it help employers with jobs created here - it also helps consumers at the end because they know the drugs they take are much safer.”
- See more at: http://energycommerce.house.gov/icymi/upton-touts-committee%E2%80%99s-landmark-drug-quality-and-security-law-during-visit-michigan-drug#sthash.rGoaQaaQ.dpuf

Very Scary--And Shows different Concentrations used by compounding pharmacies in medications for kids

ANN ARBOR: U-M leads state effort to create new standards for kids’ medicine, reduce medication errors - Ann Arbor Journal - Heritage Newspapers

Bill introduced into Colorado to allow prescription drug outlet to distribute compounded drugs for office use to hospitals

SB14-095	Pharmacies Compounding Drugs For Hospitals
Amendments:
Date Introduced:	2014-01-22
Status:	02/11/2014 Introduced In House - Assigned to Health, Insurance, & Environment
Summary:	Under current law, a prescription drug outlet may only distribute compounded drugs for office use to practitioners who are authorized to prescribe drugs. The bill allows a prescription drug outlet to also distribute compounded drugs to a hospital located in Colorado.
Calendar Notification:	Tuesday, March 4 2014 Health, Insurance & Environment Upon Adjournment Room 0107 (1) in house calendar.
Sponsors:	KEFALAS / MCCANN

What Do the New Sterile Compounding Pharmacy Regulations Mean to You?

What Do the New Sterile Compounding Pharmacy Regulations Mean to You?

4th Circuit Court of Appeals Issues Decision holding that because compliance with cGMPs is not required for payment by Medicare and Medicaid, the defendant had not falsely stated compliance to the government as contemplated by the FCA.

Link to the case: http://www.ca4.uscourts.gov/Opinions/Published/122431.P.pdf

 

FDA to enhance drug import security

read here

FDA to boost India staff overseeing drug imports

By MATTHEW PERRONE, Associated Press
Feb. 21, 2014 1:22PM PST Feb. 21, 2014 1:22PM PST
WASHINGTON (AP) — The head of the Food and Drug Administration said Friday that her agency will add more inspectors in India to better monitor drugs from the country's burgeoning pharmaceutical industry, even as her agency also seeks closer cooperation from Indian regulators.
FDA Commissioner Margaret Hamburg said the FDA will expand to 19 staffers in India from its current 12, as the U.S. tries to assure the safety of medications from companies like Ranbaxy Laboratories Ltd. and Wockhardt Ltd. Hamburg spoke with reporters following an eight-day trip to the Southeast Asian nation, where she met with Indian health regulators and drug industry executives.
With sales of more than $26 billion, India's burgeoning drug sector has grown into the U.S.'s second-largest supplier of prescription and over-the-counter medications, behind only Canada.
But that growth has come with increased scrutiny. And in recent years the FDA has issued a stream of warnings letters and import bans to some of India's largest drugmakers over manufacturing and quality control problems.
The capstone of Hamburg's visit was a "statement of intent" agreement between the U.S. and India, in which both parties pledged to cooperate on safety and quality inspections. Under the non-binding agreement, Indian inspectors will be able to shadow their FDA counterparts as they inspect factories in India. The document is supposed to cover a 5-year preliminary period, though it's unclear how or when it might lead to more formal requirements.
continue to read here

FDA wants to revamp its nonprescription drug regulations

 

 By Matthew Perrone,                

The Food and Drug Administration is seeking to revamp its system for regulating hundreds of over-the-counter drugs, saying the decades-old process is not flexible enough to keep pace with modern medical developments.
In a federal posting Friday, the agency announced a two-day meeting next month to discuss overhauling the system known as the over-the-counter monograph.
continue to read here

 

Job Opening: Compounding Pharmacy Business Manager (Bellevue)

Compounding Pharmacy Business Manager (Bellevue)

Paramount Pharmacy is looking for an outstanding full-time (100% FTE) Compounding Pharmacy Business Manager with pharmacy billing experience to join our Pharmacy team. This position requires Pharmacy Technician licensure and is responsible for assisting Paramount Pharmacy by performing non-professional/technical tasks related to delivery of pharmaceutical services.

These functions may include:
•Verification of Benefits with Patients prior to filling prescription
•Customer Service
•Pharmacy Billing (finalizing submission)
• Revenue Cycle Management
•Adheres to Paramount Pharmacy Services policies and procedures
• Performs related duties as required
•The successful candidate will build and manage a customer service team of pharmacy technicians

Paramount Pharmacy offers a comfortable work environment, excellent benefits, a competitive salary. This position provides opportunities to work in a fast-paced, challenging, diverse and rewarding environment.

Requirements:
•Compound Pharmacy Billing experience as a Pharmacy Technician or equivalent education/experience.
•Must pass background check and drug test

Legal Requirement:
•Pharmacy Technician licensure with State of Washington (Dept. of Health)
•Desired: More than 1 year of Compound Pharmacy Technician experience or significant customer service experience preferred.

quoted from here

Demand for compounded drugs grows as awareness increases - Dothan Eagle: News

Demand for compounded drugs grows as awareness increases - Dothan Eagle: News

Ninth Question of the Day February 21, 2014 Should patients be able to demand copies of sterility/potency test when they pick up their compounded prescription from their pharmacy?

Eighth Question of the Day February 21, 2014 Should a compounding ethics course be mandatory in all pharmacy schools?

Seventh Question of the Day February 21, 2014 Should any pharmacy and medical establishment doing a high volume of pain compounds be audited and investigated?

Sixth Question of the Day February 21, 2014 Will compounding pharmacies who plan only to do patient-specific compounds be able to stay in business doing just patient-specific compounds?

New Mexico passes bill to crack down on horse racing cheaters; Governor Will Sign Bill Into Law Within Next Three Weeks

By Rob Nikolewski on February 21, 2014
 Print This Post

By Rob Nikolewski │ New Mexico Watchdog
SANTA FE  – After developing a reputation as a haven for cheaters, New Mexico is trying to clean up its act when it comes to horse racing.
In the just-completed 30-day legislative session, lawmakers in Santa Fe, lawmakers passed a bill aimed at cracking down on trainers and owners who dope their horses with performance-enhancing drugs.
“I say that horse racing is the sport of kings and we don’t want it to be the sport of cheaters,” said Sen. Mary Kay Papen, D-Las Cruces, of Senate Bill 116, which passed both chambers of the New Mexico legislature unanimously. Gov. Susana Martinez has indicated she will sign the bill into law in the within the next three weeks.

- See more at: http://newmexico.watchdog.org/20577/new-mexico-passes-bill-to-crack-down-on-horse-racing-cheaters/#sthash.Z4rAjKJ6.dpuf

Fifth Question of the Day February 21, 2014 What legal warranties are provided with compounded medications?

Fourth Question of the Day February 21, 2014 Do most consumers realize that if a compounding pharmacy says its compounds "passed" a sterility test does not guarantee that every unit in that batch is sterile?

Third Question of the Day February 21, 2014 Should there be tort liability on the part of pharmacies, pharmacists, hospitals, doctors, etc. for the failure to warn or notify patients that compounded drugs have not been clinically studied and or not FDA approved?

Second Question of the Day February 21, 2014 Manufactured drugs go through pre, in and post processes of quality and performance testing ( and even at that some still end up causing great harm to patients); compounded drugs go through little or in most case none of these type studies and testing. From a legal liability stand point, this theory has not been devloped in the court system. Should it be?

 

Question of the Day February 21, 2014 What are the risk of taking HCG as a diet add in a compounded nasal spray?

This pharmacy, Benevere, offers it. see here  How many other compounding pharmacies are offering it?

Hospital Pharmacist To Work On Goal of Providing Compounds

February 20th, 2014

Dr. Rosita Rodriguez Proteau is the new pharmacist at the OSU Veterinary Teaching Hospital. She received her pharmacy degree and Ph.D. degree in Pharmacology/Toxicology from the University of Texas at Austin and has worked in the OSU College of Pharmacy as an Associate Professor for the past 17 years.
Dr. Proteau has taught pharmaceutics and pharmacokinetics in the College of Pharmacy’s professional program and toxicokinetics in the Department of Environmental and Molecular Toxicology.
Over the years, Dr. Proteau has collaborated with many investigators on campus in various pharmacokinetic studies in a variety of species.  Here at CVM, she will assist Dr. Brian Bowers in setting up a 797 sterile drug room such that the Veterinary Hospital Pharmacy can expand the options for compounded drugs.
Dr. Proteau will continue to teach in the College of Pharmacy by offering Advanced Compounding and Veterinary Pharmacy electives to the Pharm.D. students.  In her spare time, she enjoys spending time on the coast and traveling.
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Court filing: Missouri finds new pentobarbital supplier ahead of next week's planned execution

read here

Critical Intravenous Solution Shortages

Critical Intravenous Solution Shortages

The View From the FDA

Laurie Scudder, DNP, NP, Valerie Jensen, RPh

Disclosures February 20, 2014
read here

MUST WATCH! Dingell Questions FDA Commissioner Hamburg on Compounding --YouTube Video on Compounding Explaining Needs and Risks

watch here

Abbott Laboratories Recall of Veterinary Meloxicam

Veterinary	OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain	*** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014. *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05 -2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.	Class II	Some particles were observed in a limited number of OroCAM units. The particles if present could clog the pump mechanism and could also potentially result in under-administration.	Abbott Laboratories
Food	BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lot 2463	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2393, 2433, 2443, 2453, 2503, 2523, 2533, 2713, 2723, 2733	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2283, 2333, 2343, 2413, 2813	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lots 2333, 2763, 2813	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lots 2163, 2243, 2253, 2423, 2473, 2583, 2593, 2743, 2753, 2813	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lot 2233	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lots 2183, 2193, 2413, 2483, 2493, 2593, 2803, 2813	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lots 2383, 2393, 2433, 2443, 2453, 2523, 2543, 2733, 2773, 2783	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.	Lots 2113, 2523, 2533, 2543, 2773, 2783, 2843	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2743, 2753, 2763, 2863	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.	Lots 2143, 2173, 2613, 2633, 2683, 2693, 2703	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.	Lots 2143, 2173, 2323, 2603, 2623, 2683, 2693	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.	Lots 2263, 2353, 2403, 2833, 2863, 2873	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.	Lots 2413, 2643, 2663, 2673, 2883	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.	Lots 2653, 2663	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lot 2813	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lot 2673	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lot 2763	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2343, 2353, 2413, 2423, 2483, 2633, 2663, 2673, 2703, 2713, 2723, 2743, 2753, 2763, 2803, 2813, 2823, 2833, 2853, 2863, 2893	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2613, 2633	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2143, 2243, 2253, 2263, 2413, 2423, 2633	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2143, 2163, 2213, 2243, 2253, 2263, 2333, 2343, 2403, 2413, 2703	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2413, 2833	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2683, 2873	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2173, 2203, 2363, 2393, 2463, 2483, 2493, 2503, 2593, 2603, 2623, 2643, 2653, 2663, 2883	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2603, 2623	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2173, 2183, 2203, 2223, 2273, 2283, 2303, 2593, 2603, 2623	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2203, 2223, 2363, 2503, 2583, 2683, 2173, 2203, 2213, 2223,2273, 2433, 2463, 2483, 2493, 2503, 2513, 2623, 2653, 2673,2763	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2773, 2783, 2843	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2133, 2293, 2373, 2453, 2533, 2543, 2573, 2733, 2773, 2783,2793, 2803, 2843, 2853, 2260, 2383, 2402	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2213, 2283	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags.	Lots 2333, 2483, 2493, 2613	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.	Lots2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.	Lots 2193, 2323, 2693, 2803	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.	Lots 2193, 2323, 2693, 2803	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.	Lots 2573, 2583, 2593, 2693	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.	Lots 2373, 2383, 2393, 2433, 2503, 2543, 2773, 2783, 2793, 2843,2853	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.	Lot 2203	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Food	Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.	Lots 2323, 2613	Class II	Products were recalled due to possible Listeria monocytogenes contamination.	El Encanto, Incorporated
Devices	Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile	Catalog no. 2124-1400 All lots	Class II	Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.	Stryker Howmedica Osteonics Corp.
Devices	***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.	Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.	Class II	RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.	RTI Surgical, Inc.
Drugs	Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.	Lot# 605957A, Exp 09/14	Class II	Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.	Watson Laboratories, Inc.-(Actavis) - Florida
Drugs	VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.	Lot #: 67603, Expiry: 2/2014	Class III	Failed Stability Testing: This product is below specification for preservative content.	Bracco Diagnostics Inc
Devices	Product trade name t:slim" Insulin Delivery System Generic name Insulin Infusion Pump 510(k) Number K111210 cleared on Nov. 9, 2011 Description of the product - The Tandem t:slim" Insulin Delivery System ( t:slim System or t:slim ) is an Insulin Infusion Pump, product code LZG, per 21 CFR 880.5725. The t:slim System consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump ( t:slim Pump ) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedical s Comfort" Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump s internal battery, cartridge Instructions for Use, and User s Guide.	Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.	Class I	Tandem Diabetes Care®, Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandem s internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.	Tandem Diabetes Care Inc
Devices	Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void	A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147	Class II	Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.	Medtronic Sofamor Danek USA Inc
Food	PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g) packaged in a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178. MADE IN HOLLAND FOR: PASKESZ CANDY CO., Inc. Brooklyn, NY 11232.	all lots	Class I	Paskesz Candy Co., Inc. has recalled PREMIUM BELGIAN CHOCOLATE coins due to Undeclared Milk.	Paskesz Candy Co.,Inc.
Food	Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz. UPC 62013360015 3 2	20140111, 2014AL20, and 2014JL23. The last two lot codes were part of the first expanded recall. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December, 2013. The 1/23/14 announcment states Up to and including Best Before 2014AU09, 20140809, and 140809.	Class I	Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.	Unified Western Grocers Inc
Food	Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 g/ 16 oz UPC 62013300512 2	20140502, and 20140417. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The 1/23/14 notice states up to and including Best Before 2015JA06, 20150106, and 150106.	Class I	Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.	Unified Western Grocers Inc
Food	Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1.	2014AL15, 2014JN24, 2014MA07, and 2014JL29. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The new notification states Up to and including Best Before 2014AU10, 20140810, and 140810..	Class I	Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.	Unified Western Grocers Inc
Food	Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten free, dairy free, nut free. 210 g/7.4oz Qty/pkg - 6 UPC 62013300199 8	2014AL15, 2014JN25, and 2014JL14. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The expanded recall notice dated 1/23/14 states up to and including 2014AU11, 20140811 and 140811.	Class I	Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.	Unified Western Grocers Inc
Devices	GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH	Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229, 9231.	Class II	The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.	Philips Medical Systems (Cleveland) Inc
Food	Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C. Farm to Market Bread Co., Kansas City, MO.	No lot number or use by date.	Class II	The product label does not list wheat flour as an ingredient. Undeclared allergen.	Farm To Market Bread Co Inc
Devices	Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.	Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date.	Class II	Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.	Integra LifeSciences Corp.
Food	Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886	Lot codes: 2013NO25 20131125 131125 2013NO26 20131126 131126 2013DE03 20131203 131203 2013DE11 20131211 131211 2013DE22 20131222 131222 2013DE23 20131223 131223 2013DE24 20131224 131224 2013DE30 20131230 131230 2014JA04 20140104 140104 2014JA11 20140111 140111 2014JA15 20140115 140115 2014JA19 20140119 140119 2014JA28 20140128 140128 2014JA29 20140129 140129 2014FE02 20140202 140202 2014FE09 20140209 140209 2014FE11 20140211 140211 2014FE19 20140219 140219 2014FE22 20140222 140222 2014MR11 20140311 140311 2014MR30* 2014AL27* 20140427* 2014AL15* 2014AL16* 2014AL20* 2014MA19* 2014JN11* 2014JL23* 2014MA21* 2014JN22* 2014NO28* 2014MA27* 2014JN23* 2014JL29* 2014JN02* 2014JL01* 2014AU04* 2014JN03* 2014JL05* 2014AU05* 2014JN04* 2014JL15* 2017JN07* 2014JL21*	Class I	Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.	Natures Best Inc
Food	Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556	Lot codes: 2014AL16 20140416 140416 2014AL17 20140417 140417 2014AL23 20140423 140423 2014AL24 20140424 140424 2014AL26 20140426 140426 2014AL29 20140429 140429 2014MA02 20140502 140502 2014MA06 20140506 140506 2014MA15 20140515 140515 2014MA16 20140516 140516 2014MA22 20140522 140522 2014MA30 20140530 140530 2014MA31 20140531 140531 2014JN03 20140603 140603 2014JN05 20140605 140605 2014JN10 20140610 140610 2014JN11 20140611 140611 2014JN13 20140613 140613 2014JN21 20140621 140621 2014JN28 20140628 140628 2014JL04 20140704 140704 140927* 2014SE27* 20140927* 2014OC15* 20141016* 2014OC16* 2014OC18* 141021* 2014OC21* 2014NO01* 2014NO07* 2014DE11* 2014NO05* 2014NO25*	Class I	Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.	Natures Best Inc
Food	Original Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001981, NB Item #616953	Lot codes: 2013DE09 20131209 131209 2013DE31 20131231 131231 2014JA26 20140126 140126 2014MR10 20140310 140310 2014MR15 20140315 140315 2014MR16 20140316 140316 2014AL15* 2014MA07* 2014JN24* 2014AL29* 2014JN10* 2014JL13* 2014JL29*	Class I	Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.	Natures Best Inc
Food	Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item #616961.	Lot codes: 2013DE25 20131225 131225 2014JA27 20140127 140127 2014AL15* 2014JN25* 2014AU10* 2014AL29* 2014JL13* 2014AU11* 2014MA28* 2014JL14*	Class I	Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.	Natures Best Inc
Food	Bread & Bun Mix, 16.4oz, Qty/pkg: 6, UPC 620133105504, NB Item 645564	Lot codes: 2014AL04 20140404 140404 2014MA09 20140509 140509 140905* 2014NO20* 2014OC25* 2014DE19*	Class I	Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.	Natures Best Inc
Food	Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com	UPC Codes 729440332044, 729440332006, 729440332051, 729440332037, 729440332075, 729440332082	Class II	Product may contain undeclared allergens	Araya, Inc
Food	Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com	UPC Codes 760921366004, 760921366011, 760921366066, 760921366003, 760921366097, 760921366073, 760921366028	Class II	Product may contain undeclared allergens	Araya, Inc
Food	Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com	UPC Codes 729440332082, 729440332105, 729440332136	Class II	Product may contain undeclared allergens	Araya, Inc
Food	Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com	UPC Codes 729440332167, 729440332488, 729440332235	Class II	Product may contain undeclared allergens	Araya, Inc
Food	Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com	UPC Code 729440332402	Class II	Product may contain undeclared allergens	Araya, Inc
Devices	Horizon Medical Imaging, Picture Archive Communication System (PACS).	HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.	Class II	Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.	Mckesson Information Solutions LLC
Food	Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code 0 38000 84496 6 Ingredients: INGREDIENTS: DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFLOWER OIL), CORN FLOUR, WHEAT STARCH, MALTODEXTRIN, SALT, RICE FLOUR AND DEXTROSE. CONTAINS WHEAT INGREDIENTS Product was placed in 226 display shippers with a variety of Pringles products. PRINGLES US 4-FLV 84ct ALT SHPR UPC 38000 84832 PRINGLES US 3FLV MXD 728/164G PALLET UPC 38000 84620	individual cans codeL 3269KT70 0830 - L 3269KT70 0930 BEST BY 12/26/2014 Manufacturing Code on Shippers PRINGLES US 4-FLV 84ct ALT SHPR KT 12064C and KT12074A PRINGLES US 3FLV MXD 728/164G PALLET KT 12264	Class I	Undeclared milk, an allergen	Kellogg Company
Food	Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free	Up to and including Best Before 2014AU09, 20140809, 140809	Class I	contains undeclared milk	Braum's Ice Cream and Dairy
Food	Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack	Lot #'s 1024020A and 1023020B (Products also contain a BEST BEFORE NOV 15 14 code, and UPC code 2113010895)	Class II	product has the potential to be contaminated with Listeria monocytogenes	Windsor Frozen Foods
Devices	Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.	510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB	Class II	Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.	Stryker Howmedica Osteonics Corp.
Drugs	Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland.	Lot #: 13J081, Exp 05/15	Class II	Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.	Actavis Inc
Food	Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)	Lot: 290712 (290712 MFG July 2012)	Class I	Gano Excel USA is recalling the C'Real Spirulina because it contains undeclared wheat and soy.	Gano Excel USA Inc
Biologics	Bermuda Grass	B29032613;	Class III	One lot of Standardized Bermuda Grass Pollen Allergenic Extract, with a decreased potency, was distributed.	Antigen Laboratories Inc
Drugs	Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01	Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14	Class II	Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.	Mylan Pharmaceuticals Inc.
Drugs	Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....	Lot #: JKM7075A, Expiry:10/15	Class II	Failed Tablet Specifications: Broken Tablets Present.	Caraco Pharmaceutical Laboratories Ltd.
Devices	Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.	16397693	Class II	Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.	Boston Scientific Corporation
Devices	Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.	16310947	Class II	Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.	Boston Scientific Corporation

 

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Enforcement Report - Week of February 19, 2014

Enforcement Report - Week of February 19, 2014

Reminder: Pharmacy Compounding: An Update from The Joint Commission, the Food and Drug Administration (FDA), and the American Society of Health-System Pharmacists (ASHP)

 

Thursday, February 27, 2014 - 12:00 PM - 01:00 PM (CT)

Short Description:
The Joint Commission’s requirements for the compounding of human drugs, and tools organizations can use to assure the safety of compounded products.

• Overview
• Registration

Attendance is limited to 1,000 people.  A replay will be posted on The Joint Commission website after the webinar and the link to the replay will be published in Joint Commission Online.

Queensland Health confirms 17 cancer patients given contaminated drugs in hospital

The health of 17 cancer patients in hospitals in Queensland has been put at serious risk by a contaminated batch of drugs, authorities say.

Queensland Health says the patients were in public and private hospitals across the state.
Department spokeswoman Dr Jeannette Young says the patients have been receiving chemotherapy and the contaminated drugs could be a major risk to their weakened immune systems.
She says after receiving the advice, doctors were immediately asked to check on the wellbeing of those patients.
Dr Young says the patients who took the drugs have not suffered any adverse effects to date, but are being closely monitored by their clinicians.
The Therapeutic Goods Administration (TGA) issued a product recall notice for compounded drugs manufactured by Fresenius Kabi Australia Proprietary Limited last Thursday.
The TGA says a risk assessment by Fresenius Kabi found there is a potential risk for patients as the sterility of product may have been compromised.
Fresenius Kabi has not received any reports of adverse events associated with this failure.
She says affected stocks of the suspect drug have now been recalled.
quoted from here

Cancer patients given contaminated compounded drugs in Australia: TGA advised compounded drugs manufactured by Fresenius Kabi Australia had been recalled, after the company concluded "there is a potential risk for patients as the sterility of product may have been compromised".

Cancer patients given contaminated drugs

read here