D-0168-2016 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
- 2 vials
Product Description
Testosterone prop. 200 mg/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
07282015@8, exp 10/26/2015, 07302015@4, exp 10/28/2015