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Class II: temporary or reversible health riskTerminated

Pacific Healthcare, Inc dba B&B Pharmacy Papa+Pge1+Phento Recall

PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health…

Pacific Healthcare, Inc dba B&B Pharmacy · Bellflower, CA

Risk level
Class II
Reported by FDA
Nov 18, 2015
Recall ID
D-0169-2016
Check your lot numberHow we source this data

Summary

Pacific Healthcare, Inc dba B&B Pharmacy recalled Papa+Pge1+Phento starting Oct 7, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0169-2016 on Nov 18, 2015. Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Product description

PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Lot numbers, UPCs & expiration codes

5 mL 06022015@11, exp 11/29/2015; 06082015@5, exp 12/5/2015; 06112015@7, exp 12/8/2015; 06112015@9, exp 12/8/2015; 06162015@7, exp 12/13/2015; 07092015@6, exp 1/5/2016; 07092015@7, exp 1/5/2016; 07162015@4, exp 1/12/2016; 07202015@1, exp 1/16/2016; 07202015@2, exp 1/16/2016; 08032015@6, exp 1/30/2016; 08142015@12, exp 2/10/2016; 08142015@13, exp 2/10/2016; 08142015@7, exp 2/10/2016; 08182015@14, exp 2/14/2016; 08242015@6, exp 2/20/2016 --- 10 mL 05042015@4, exp 10/31/2015; 06012015@6, exp 11/28/2015; 06022015@12, exp 11/29/2015; 06032015@5, exp 11/30/2015; 06082015@4, exp 12/5/2015; 06082015@5, exp 12/5/2015; 06112015@4, exp 12/8/2015; 06152015@10, exp 12/12/2015; 06162015@6, exp 12/13/2015; 06232015@12, exp 12/20/2015; 07012015@1, exp 12/28/2015; 07092015@8, exp 1/5/2016; 07132015@2, exp 1/9/2016; 07152015@10, exp 1/11/2016; 07162015@6, exp 1/12/2016; 07272015@4, exp 1/23/2016; 07282015@3, exp 1/24/2016; 07282015@4, exp 1/24/2016; 07282015@5, exp 1/24/2016; 07292015@4, exp1/25/2016; 08032015@2, exp 1/30/2016; 08032015@7, exp 1/30/2016; 08142015@10, exp 2/10/2016; 08142015@11, exp 2/10/2016; 08142015@2, exp 2/10/2016; 08142015@4, exp 2/10/2016; 08142015@6, exp 2/10/2016; 08142015@8, exp 2/10/2016; 08182015@12, exp 2/14/2016; 08182015@13, exp 2/14/2016; 08312015@4, exp 2/20/2016

Where it was sold

CA and NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0169-2016
Classification
Class II
Status
Terminated
Recall initiated
Oct 7, 2015
FDA report date
Nov 18, 2015
Quantity
31 -10 ml vials; 16- 5 ml vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pacific Healthcare, Inc dba B&B Pharmacy

Original FDA data

Every field from FDA enforcement report D-0169-2016, exactly as published.

Show all FDA fields
City
Bellflower
State
CA
Status
Terminated
Country
United States
Event ID
72361
Address
10244 Rosecrans Ave
Code information
5 mL 06022015@11, exp 11/29/2015; 06082015@5, exp 12/5/2015; 06112015@7, exp 12/8/2015; 06112015@9, exp 12/8/2015; 06162015@7, exp 12/13/2015; 07092015@6, exp 1/5/2016; 07092015@7, exp 1/5/2016; 07162015@4, exp 1/12/2016; 07202015@1, exp 1/16/2016; 07202015@2, exp 1/16/2016; 08032015@6, exp 1/30/2016; 08142015@12, exp 2/10/2016; 08142015@13, exp 2/10/2016; 08142015@7, exp 2/10/2016; 08182015@14, exp 2/14/2016; 08242015@6, exp 2/20/2016 --- 10 mL 05042015@4, exp 10/31/2015; 06012015@6, exp 11/28/2015; 06022015@12, exp 11/29/2015; 06032015@5, exp 11/30/2015; 06082015@4, exp 12/5/2015; 06082015@5, exp 12/5/2015; 06112015@4, exp 12/8/2015; 06152015@10, exp 12/12/2015; 06162015@6, exp 12/13/2015; 06232015@12, exp 12/20/2015; 07012015@1, exp 12/28/2015; 07092015@8, exp 1/5/2016; 07132015@2, exp 1/9/2016; 07152015@10, exp 1/11/2016; 07162015@6, exp 1/12/2016; 07272015@4, exp 1/23/2016; 07282015@3, exp 1/24/2016; 07282015@4, exp 1/24/2016; 07282015@5, exp 1/24/2016; 07292015@4, exp1/25/2016; 08032015@2, exp 1/30/2016; 08032015@7, exp 1/30/2016; 08142015@10, exp 2/10/2016; 08142015@11, exp 2/10/2016; 08142015@2, exp 2/10/2016; 08142015@4, exp 2/10/2016; 08142015@6, exp 2/10/2016; 08142015@8, exp 2/10/2016; 08182015@12, exp 2/14/2016; 08182015@13, exp 2/14/2016; 08312015@4, exp 2/20/2016
Postal code
90706-2602
Report date
Nov 18, 2015
Product type
Drugs
Recall number
D-0169-2016
Classification
Class II
Recalling firm
Pacific Healthcare, Inc dba B&B Pharmacy
Product quantity
31 -10 ml vials; 16- 5 ml vials
Termination date
Apr 7, 2016
Reason for recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Distribution pattern
CA and NJ
Recall initiation date
Oct 7, 2015
Initial firm notification
Letter
Center classification date
Nov 10, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0169-2016, published Nov 18, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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