D-0171-2016 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
- 3 vials
Product Description
PGE 20mcg/ml Injection, 10 mL vial, 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
05072015@7, exp 11/3/2015; 05182015@3, 11/14/2015; 07152015@, 1/11/2016