D-0178-2016 Class II Terminated
FDA drug recall D-0178-2016 was initiated by Pacific Healthcare, Inc dba B&B Pharmacy on October 7, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The recall status is terminated (terminated April 7, 2016). Affected quantity: 1 vial.
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/PHENTO (15mg/0.8333mg/ml) Injection, 5 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
07082015@4, exp 1/5/2016