D-0177-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2015
- Initiation Date
- October 7, 2015
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 vials
Product Description
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution Pattern
CA and NJ
Code Information
07062015@8, exp 1/2/2016; 07162015@7, exp 1/12/2016; 07272015@5, exp 1/23/2016; 08142015@9, exp 2/10/2016