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Tuesday, August 22, 2017

Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

For Immediate Release

August 18, 2017

Contact

Consumers

877-235-5279

Media

Michael Younan
(877) 235 5279

Announcement

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance.  The recalled products were distributed to health care facilities nationwide. 
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. 
 
The following products are being affected by this recall:
 
Lot
Expiration Date   
Product Name                 
Container type    
Units Distributed
070617GL
1/6/18
Glutathione 200mg/ml
30ml Vial
82units
070717MC
1/7/18 
Methylcobalamin 1mg/ml
30ml Vial
30units
070717ML      
1/718
Mannitol 20%
10ml Vial
10units
071217GAC    
1/12/18           
GAC
30ml vial
3 units
071217CC
10/12/18
Calcium chloride 10%
10ml vial
5 units
BPBC3080517
2/5/18
B-Complex
30ml vial
45 units
BPMC30072917 
1/29/18
Methylcobalamin 10mg/ml
30ml vial
7 units
BPMC08517
2/5/18
Magnesium Chloride 200mg
30ml vial
5 units
BPLG08517
2/5/18
L-Glutamine 100mg
30ml vial
5 units 
BPMIC30072917 
1/29/18
MIC 25/50/50
30ml Vial
5 units
BPLG3508717
11/7/17           
Lidocaine Gel 3.5%
15ml dropper
6 units
BPPTC08717
11/17/17
Phenylephrine2.5%/Tropicamide 1%
15ml dropper
6 units
BPSB8408717
11/7/17
Sodium Bicarbonate 8.4%
10ml vial
20 units
BPFS41717
4/1/18
Fluorescein Sodium
5ml vial
644 units
3141201
9/13/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
30 units
3146966
 9/20/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
310 units
3160608
10/5/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
784 units
3146966
 11/1/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
646 units
“Bella Pharmaceuticals has a longstanding commitment to quality and safety.  We are voluntarily issuing a recall out of an abundance of caution after several issues were identified during a recent FDA inspection of our facility,” Michael Younan, Chairman and CEO of Bella Pharmaceuticals.  “We regret any impact this recall has on our loyal customers and their patients.”
Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products.  Anyone with product subject to the recall should stop using it and contact the company.  To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.
Consumers with questions regarding this recall can contact Bella Pharmaceuticals by 877-235-5279 or e-mail address on Monday through Friday, from 9 a.m. and 5 p.m. CST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
 
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 
###

Product Photos

  • Bella Pharma Methylcobalamin 10mg Sterile 30ml Vial-Methylcobalamin 10mg/ml Sterile Water Sodium Chloride
  • Bella Pharma Methylcobalamin 10mg Sterile 30ml Vial-Methylcobalamin 1mg/ml Sterile Water Sodium Chloride
  • Bella Pharma B-Complex Sterile 30ml Vial
  • Bella Pharma PF-GLUTATHIONE 200mg Sterile 30ml Vial
  • Bella Pharma Mannitol 20%,10ml STERILE VIAL
  • Bella Pharma G.A.C 25/100/250mg Sterile 30ml Vial
  • Bella Pharma L-Glutamine 100mg Sterile 30ml Vial
  • Bella Pharma Magnesium Chloride 200mg Sterile 30ml Vial
  • Bella Pharma Fluorescein Sodium, 5ml Sterile Injectable Dye
  • Bella Pharma M I C 25/50/50 Sterile 30ml Vial
  • Bella Pharma Lidocaine Gel 3.5%, 15ml Sterile Ophthalmic Jelly
  • Bella Pharma Pheny2.5Tropicamide1, 15ml Sterile Ophthalmic Solution
  • Bella Pharma Sodium Bicarbonate 8.4%, 10ml Sterile Solution
  • Bella Pharma Calcium Chloride, 10ml Sterile Solution
  • Bella Pharma Bevacizumab Prefilled 31g Syringe 1.25mg/0.05ml
Woman Gets $417 Million Verdict From Johnson & Johnson in Baby Powder Cancer Suit - NBC News
https://apple.news/AgHRvjGJQR62k0aKq7cARrQ
We share a lot with the animal world, and that is a good thing. But, there are times when we and animals are better off if we don’t share.
Although it’s true that people and many animals are sometimes given the same antibiotic, they shouldn’t be shared or substituted between species.
Today, the FDA issued the final version of Guidance for Industry #237 - Oncology Drugs for Companion Animals. The agency did not receive comments on the draft guidance; therefore, the final guidance contains only minor editorial changes.

New ASHP Book Helps You Understand USP <800> Compliance

Pharmacy Practice News-14 hours ago
... technicians and other health professionals involved in the compounding and ... Ms. Kienle also talked with Pharmacy Practice News columnist Ernest R.

meningitis-etc: 2nd Wave of Checks Enroute to Victims

meningitis-etc: 2nd Wave of Checks Enroute to Victims: By Walter F. Roche Jr. A second wave of checks to victims of a deadly meningitis outbreak has begun to arrive and for some, at least, it ...

Monday, August 21, 2017

Must Read! June 2017 issue of The Script from the California Board of Pharmacy

California Board of Pharmacy Board Actions at July 25-26 Meeting including items relating to compounding

Age Well, PHY 49116, Administrative Case AC 5972
Lompoc, CA
Accusation Filed 6/30/2017; Case pending.
View the accusation
B&B Pharmacy, PHY 50799, Administrative Case AC 6022
Bellflower, CA
Accusation Filed 6/30/2017; Case pending.
View the accusation
B&B Pharmacy, LSC 99714, Administrative Case AC 6022
Bellflower, CA
Accusation Filed 6/30/2017; Case pending.
View the accusation
Value Care Pharmacy, PHY 54247, Administrative Case AC 5989
Anaheim, CA
Accusation Filed 6/30/2017; Case pending.
View the accusation
Value Care Pharmacy, PHY 44873, Administrative Case AC 5989
Tustin, CA
Accusation Filed 6/30/2017; Case pending.
View the accusation
American Custom Compounding Pharmacy, NRP 1262 & NSC 99778,
Administrative Case 6017
Dallas, TX
Through a disciplinary action of the Board, the license is revoked and canceled and the right to practice or operate has ended.
Decision effective 7/26/2017.
View the decision
CVS Pharmacy #1666, Administrative Case AC 4863
Lancaster, CA
Through a disciplinary action of the Board, the license is subject to a public reproval.
Decision effective 7/7/2017.
View the decision
Danville Sam Ramon Pharmacy, PHY 50868, Administrative Case 5940
Danville, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for four (4) years, and is subject to the terms and conditions in the decision. 
Decision effective 8/10/2017.
View the decision
Innovative Compounding, PHY 48417 and LSC 99600, Administrative Case 5663
Folsom, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for five (5) years, and is subject to the terms and conditions in the decision. 
Decision effective 8/10/2017.
View the decision
Medaus Pharmacy, NRP 547 and NSC 99170, Administrative Case 5859
Birmingham, AL
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for five (5) years, and is subject to the terms and conditions in the decision. 
Decision effective 8/10/2017.
View the decision
Oroville Hospital Pharmacy, HSP 41557 and LSC 100404, Administrative Case 5630
Oroville, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for three (3) years, and is subject to the terms and conditions in the decision. 
Decision effective 8/10/2017.
View the decision
Payless Pharmacy, PHY 50705, Administrative Case AC 5470
Monterey Park, CA
Through a disciplinary action of the Board, the license is revoked the revocation is stayed, and the license is placed on probation for three years and is subject to the terms and conditions in the decision.
Decision effective 8/9/2017.
View the decision
South Figueroa Drugs, PHY 40552, Administrative Case AC 5879
Through a disciplinary action of the Board, the license is revoked and canceled and the right to practice or operate has ended.
Decision effective 8/9/2017.
View the decision
St. Helena Hospital Clearlake, HSP 43172 and LSC 100039, Administrative Case 5753
Clearlake, CA
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for three (3) years, and is subject to the terms and conditions in the decision. 
Decision effective 8/2/2017.
View the decision
St. Paul’s Pharmacy I, PHY 42891, Administrative Case AC 5262
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Huntington Park, CA
Decision effective 7/14/2017.
View the decision
Strohecker’s Pharmacy, NRP 705, NRP 1806 and NSC 99432
Administrative Case AC 5784
Portland, OR
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 8/10/2017.
View the decision
Wells Pharmacy Network, NRP 1325 & NSC 99824, Administrative Case AC 5887
Dyersburg, TN
Through a disciplinary action of the Board, the license is subject to a public reproval.
Decision effective 7/26/2017.
View the decision

Missouri prepares for second execution of 2017; requests to halt it ...

St. Louis Public Radio-4 hours ago
Pentobarbital is made by one of two sources: A compounding pharmacy or an FDA-approved manufacturer. The manufacturer will not sell directly to any state for ...

US Marines used in $67 million insurance kickback scheme involving compounded drugs

US Marines used in $67 million insurance kickback scheme

Insurance Business-8 minutes ago
The accusations are relate to the latest in a number of investigations into TRICARE fraud schemes involving compounded drugs. Similar scams have resulted in ...

Guilty pleas for Linwood, Philadelphia men in federal prescription ...

Press of Atlantic City-44 minutes ago
In exchange, the doctors would receive kickbacks from an out-of-state compoundingpharmacy. Tedesco also recruited patients to request expensive, unneeded ...

FDARA: Making a Difference for Industry and Patients

FDARA: Making a Difference for Industry and Patients
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes a reauthorization of four of the medical product user fee programs, the Prescription Drug User Fee Amendments, Medical Device User Fee Amendments, Generic Drug User Fee Amendments, and Biosimilar User Fee Amendments. 
Three of FDA’s medical product center directors discuss importance of the FDA Reauthorization Act of 2017.

The Pains of Prescribing Opioids How often do we give painkillers out of selfishness?

The Center for Veterinary Medicine (CVM) is pleased to announce a CVM-only version of FDA’s eSubmitter tool. This new software package is independent from the FDA eSubmitter program. The new CVM eSubmitter tool is available for download as of August 21, 2017.
CVM eSubmitter is an electronic, question-based submission tool for creating information to be transmitted electronically to FDA through its secure Electronic Submission Gateway (ESG). eSubmitter uses data-capturing templates to allow users to assemble a complete and appropriately structured submission to CVM. The templates, available for all submission types varying from simple to complex, were developed by CVM subject-matter experts.

Sunday, August 20, 2017

20-plus health care stats that will blow you away

USA TODAY-Aug 18, 2017
$3.2 trillion: The United States spends a whopping sum on health care. The total U.S. healthcare expenditure in 2015 was $3.2 trillion, per the Centers for

FDA mulls change to drug ad rules

The Pharma Letter (registration)-Aug 18, 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing statements about drug safety in ...

FDA to Cut Back Hiring of Non-US Citizens

The Scientist-Aug 14, 2017
FDA building with sign FDAHiring managers at the US Food and Drug Administration (FDA) will soon be unable to extend offers to non-citizens who have lived ..

Congress Weighs Expanding FDA Power to Regulate Beauty Products

Congress Weighs Expanding FDA Power to Regulate Beauty Products

Wall Street Journal (subscription)-Aug 18, 2017
Yet six years after a consumer-safety group petitioned the agency to ban the products, the FDA has taken little action and said recently it is still studying the issue ...

FDA slams more homeopaths for playing fast and loose with toxic ...

Ars Technica-Aug 17, 2017
Homeolab is just the latest homeopathic company slammed by the FDA for problems related to belladonna-containing products. For years, the agency has been ...

Question of the Day August 20, 2017 Prosecutions so far for the compounding fraud scheme has span from coast to coast and involved numerous states. Are there any states were this fraud has not touched? Should states prosecute the lower level or dollar amount health care fraud and schemes? Why or why not?


"The Pharmacy Benefits Administrator paid Compounding Pharmacy over $50 million for compounded medications mailed to individuals in New Jersey, authorities said. "

Saturday, August 19, 2017

Compounding Drug salesmen plead guilty to fraud, forfeit $385 K - Courier-Post

Drug salesmen plead guilty to fraud, forfeit $385 K - Courier-Post

www.courierpostonline.com/story/news/crime/2017/08/18/...fraud/581252001/
21 hours ago - Drug salesmen plead guilty to fraud, forfeit $385K ..... Those drugs are typically mixed by a pharmacist "to meet the specific medical needs of an ... They pleaded guilty Friday in federal court in Camden to conspiring to commit healthcare fraud.
Department of Justice
U.S. Attorney’s Office
Middle District of Florida

FOR IMMEDIATE RELEASE
Friday, August 18, 2017

St. Augustine Pharmacist Pleads Guilty To $2 Million Compound Pharmacy Fraud Scheme

Jacksonville, FL – Acting United States Attorney W. Stephen Muldrow announces that Dino Ajloni (40, St. Augustine) has pleaded guilty to healthcare fraud in connection with his role in a fraudulent compound pharmacy scheme. He faces a maximum penalty of 10 years in federal prison.

According to the plea agreement, Ajloni was the operator of Wellness Pharmacy in St Augustine. He performed various jobs, including marketing prescriptions, recruiting physicians to write and fill prescriptions at Wellness Pharmacy, and other jobs.

Ajloni also relied on marketers to help recruit patients to get prescriptions filled at his pharmacy. One of these marketers brought his family in to become “patients” of Wellness Pharmacy. The pharmacy filled numerous prescriptions for the marketer’s family and received nearly $200,000 in government reimbursement. Ajloni admitted paying the marketer almost $50,000 for the referral of work, in violation of the Anti-Kickback statute.

Ajloni also recruited patients himself. For example, he offered patients access to “anything in the store” if they agreed to receive compound prescription drugs. At other times, he offered gift baskets, with chocolate, deodorant, nuts, and other accessories, to patients that accepted compounded prescriptions.

In 2016, TRICARE developed suspicions regarding the legitimacy of these compound prescriptions. Because the vast majority of Wellness Pharmacy’s claims were purportedly written by a doctor who had never separately billed for these patient visits, TRICARE asked Wellness Pharmacy to complete an audit. During the course of the audit, Ajloni and others made a variety of false and misleading statements. Among other things, Ajloni noted that all patients paid co-pays, no patient was offered anything of value to receive prescriptions, and that Wellness Pharmacy called the doctor prior to dispensing the prescriptions.

Ajloni received $1,916,206.97 in healthcare reimbursement that he was not otherwise entitled to receive.

This case was investigated by the Federal Bureau of Investigation and the Defense Criminal Investigative Service. It is being prosecuted by Assistant United States Attorney Jason Mehta.
Topic(s): 
Financial Fraud
Healthcare Fraud
StopFraud
Component(s):