D-0173-2016 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/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