D-0178-2016 Class II Terminated

Recalled by Pacific Healthcare, Inc dba B&B Pharmacy — Bellflower, CA

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