PlainRecalls
FDA Drug Moderate Class II Terminated

PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Reported: November 18, 2015 Initiated: October 7, 2015 #D-0174-2016

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

Details

Units Affected
1-5 ml vial; 3-10 ml vials
Distribution
CA and NJ
Location
Bellflower, CA

Frequently Asked Questions

What product was recalled?
PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA. Recalled by Pacific Healthcare, Inc dba B&B Pharmacy. Units affected: 1-5 ml vial; 3-10 ml vials.
Why was this product recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 18, 2015. Severity: Moderate. Recall number: D-0174-2016.