Recalls / Class II
Class IID-0176-2016
Product
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Affected lot / code info
- 5 ml --- 07062015@1, exp 1/2/2016; ---- 10 ml --- 07272015@3, exp 1/23/2016
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recalling firm
- Firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10244 Rosecrans Ave, N/A, Bellflower, California 90706-2602
Distribution
- Quantity
- 1- 5ml vial, 1- 10 ml vial
- Distribution pattern
- CA and NJ
Timeline
- Recall initiated
- 2015-10-07
- FDA classified
- 2015-11-10
- Posted by FDA
- 2015-11-18
- Terminated
- 2016-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0176-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.