Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lot numbers, UPCs & expiration codes
05072015@7, exp 11/3/2015; 05182015@3, 11/14/2015; 07152015@, 1/11/2016
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-0171-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2015
- FDA report date
- Nov 18, 2015
- Quantity
- 3 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-0171-2016, 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
- 05072015@7, exp 11/3/2015; 05182015@3, 11/14/2015; 07152015@, 1/11/2016
- Postal code
- 90706-2602
- Report date
- Nov 18, 2015
- Product type
- Drugs
- Recall number
- D-0171-2016
- Classification
- Class II
- Recalling firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Product quantity
- 3 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
- PGE 20mcg/ml Injection, 10 mL vial, 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