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/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lot numbers, UPCs & expiration codes
5 ml --- 07062015@2, exp 1/2/2016 10 ml --- 06042015@4, exp 12/1/2015; 06052015@15, exp 12/2/2015; 07132015@3, exp 1/9/2016
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-0174-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2015
- FDA report date
- Nov 18, 2015
- Quantity
- 1-5 ml vial; 3-10 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-0174-2016, 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 --- 07062015@2, exp 1/2/2016 10 ml --- 06042015@4, exp 12/1/2015; 06052015@15, exp 12/2/2015; 07132015@3, exp 1/9/2016
- Postal code
- 90706-2602
- Report date
- Nov 18, 2015
- Product type
- Drugs
- Recall number
- D-0174-2016
- Classification
- Class II
- Recalling firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Product quantity
- 1-5 ml vial; 3-10 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/10mg/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