D-0174-2016 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
- 1-5 ml vial; 3-10 ml vials
Product Description
PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 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
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