Showing posts with label Recall. Show all posts
Showing posts with label Recall. Show all posts

Thursday, January 16, 2014

VERY IMPORTANT!! Recall of all lots of Sterile Products Compounded with Expiry From Compounding Centre at Blue Ridge in NC due to recent FDA inspection and lack of assurance of steriility

Drugs Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
quoted from here

Tuesday, September 17, 2013

Avella of Deer Valley, Inc., Phoenix, AZ 483 and press release regarding recall on 9/9/2013


Avella of Deer Valley, Inc, Phoenix, AZ
  • Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (9/9/2013)
  • 483 Issued 2/25/2013 (PDF - 1010KB)

Saturday, March 16, 2013

Voluntary recall of medical products from Tinton Falls pharmaceutical company

By Tomas Dinges/The Star-Ledger 
on March 16, 2013 at 12:32 AM, updated March 16, 2013 at 1:05 AM


The state is recommending medical products from a Monmouth County company be taken off the shelves and production halted after concerns that bags of intravenous fluid may be contaminated, officials said.
Bags of magnesium sulfate solution produced by Tinton Falls-based Med Prep
Consulting
 shipped to a Connecticut hospital may have been contaminated with visible floating particles, according to a release late Friday night by state Attorney General Jeffrey Chiesa and Health Commissioner Mary E. Dowd.
The recall also includes magnesium sulfate products that “may have been dispensed to additional facilities elsewhere, including New Jersey and Pennsylvania,” according to the statement released late last night.
As a precautionary measure, any health care facility that has received products from the company should remove them from use, said O’Dowd.
It is unclear how many other medical facilities received the products made by Med Prep.
Officials confirmed bags of the solution were sent to the Yale New Haven Hospital in New Haven.
As of Friday, the company entered into a voluntary consent order with the state until at least March 22 and agreed to halt all operations, including the production and shipment of medications, officials said.
"The State Board of Pharmacy and Med Prep have agreed that the pharmacy will stop producing and shipping medications until additional information about the potentially contaminated products can be gathered and analyzed,” Chiesa said.
State agencies are monitoring the situation along with the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention and Connecticut’s department of health.
Studies have shown that magnesium sulfate taken intravenously can reduce the incidence of cerebral palsy in babies when infused into their pregnant mothers, and also act as an anticonvulsant and replenisher of electrolytes to prevent seizures in pregnant women, according to the National Institutes of Health.
Source found here

Thursday, February 28, 2013

Hospira issues 3 recalls as it faces crucial FDA inspection

February 27, 2013 | By 

Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.


Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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Monday, February 25, 2013

Feb 25, 2013, 11:03am EST: Recall from Village Fertility Pharmacy--6 products over three years


Waltham, Mass.-based Village Fertility Pharmacy has issued a voluntary recall of several compounded products, after a foreign substance was detected in a small percentage of two lots of the fertility drug progesterone. The pharmacy said it contacted the Massachusetts Board of Pharmacy immediately after discovering the particulate matter.
The recall includes six different products shipped over the past three months. They include five progesterone products and one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.
“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” Village Fertility Pharmacy president Stuart Levine said in a statement. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”
The recall includes the following products:
* Progesterone Injection Cottonseed Oil 50 MG/ML
* Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML
* Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML
* Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML
* Hydroxy Progesterone Caproate 250 MG/ML
* Compounded Leuprolide Acetate 1MG/.2ML
Progesterone is a hormone that supports pregnancy and it is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.
Village Fertility Pharmacy said that only 5 percent of its overall business comes from compounded products.
source found here

Sunday, February 24, 2013

BREAKING NEWS: Massachusetts Specialty Pharmacy Announces Voluntary Recall


WALTHAM, Mass.--()--Village Fertility Pharmacy is conducting a voluntary recall of compounded medications shipped over the past three months. The recall resulted after particulate was discovered in a small percentage of two lots of Progesterone. Immediately upon learning of the situation, Village contacted the Massachusetts Board of Pharmacy.
“We are working cooperatively with all government agencies and are awaiting the results of the investigation”
After an initial investigation, Village and the Massachusetts Board of Pharmacy decided to expand the recall to include one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.
“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” according to Stuart Levine, president of Village Fertility Pharmacy. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”
The recall includes:
  • Progesterone Injection Cottonseed Oil 50 MG/ML
  • Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML
  • Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML
  • Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML
  • Hydroxy Progesterone Caproate 250 MG/ML
  • Compounded Leuprolide Acetate 1MG/.2ML
Progesterone is a hormone that supports gestation. It is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.
Village Fertility Pharmacy is a pharmacist-owned and operated specialty fertility pharmacy dedicated to providing exceptional service and educational resources to fertility patients and clinics. Compounding represents five percent of the company’s total work.
Patients with questions can call the Village Recall Hotline at 1-888-965-5813.

Contacts

For Village Fertility Pharmacy
Matt Ellis, 617-278-6560
matt@ballcg.com

Monday, September 3, 2012

Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads


[Posted 08/29/2012]
AUDIENCE: Risk Manager, Pharmacy
ISSUE: FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition Compounder Systems, due to incorrect key press responses, caused by fluid entry into device keypads, and intermittent electrical failures. Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.
The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death.
BACKGROUND: Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.
RECOMMENDATION: Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call             1-800-332-1088       to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/29/2012 - Recall Notice - FDA]

Saturday, August 18, 2012

The minutes from the May 2012 Texas State Board of Pharmacy have been posted.  The minutes relating to compounded preparations are as follows:

Rules Concerning Recall Procedures for Compounded Preparations
(§§291.131 and 291.133) (Tab 13)
Ms. Benz directed the Board’s attention to suggested amendments to
§§291.131 and 291.133 and explained the amendments clarify the
requirements for the recall of compounded preparations. Ms. Benz
recommended that the proposed rule be changed so that written
notifications to the Board concerning recalls be limited to batch
preparations only.
Following discussion, the motion was made by Mr. Wetherbee to
approve for proposal amendments to §§291.131 and 291.133 with
changes recommended by Board staff. The motion was seconded by
Ms. Mendoza and passed unanimously.

Entire minutes can be viewed here.

Friday, July 27, 2012

August Meeting Agenda of Texas Board of Pharmacy Includes Recall Procedure Amendments Again


To view the August 2012 agenda for the Texas Board of Pharmacy meeting, click here.  On the agenda again in August for discussion are the amendments relating to the recall of compounded preparations

RULE ANALYSIS
Introduction: THESE AMENDMENTS ARE SUBMITTED TO THE BOARD FOR CONSIDERATION AS ADOPTED RULES
Short Title: Recall Procedures
Rule Numbers: §§291.131, 291.133
Statutory Authority: Texas Pharmacy Act, Chapter 551-566 and 568-569, Occupations Code:
(1) Section 551.002 specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; and
(2) Section 554.051 gives the Board the authority to adopt rules for the proper administration and enforcement of the Act.
Purpose: The amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Background: Board staff presents these recommendations to clarify the recall procedures for pharmacies compounding sterile and non-sterile preparations.
The Board reviewed and voted to propose the amendments during the May 8, 2012, meeting. The proposed amendments were published in the June 22, 2012, issue of the Texas Register at 37 TexReg 4523.