D-0173-2016 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
- 1 vial
Product Description
PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/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
06012015@8, exp 11/28/2015