PlainRecalls
FDA Drug Moderate Class II Terminated

PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Reported: November 18, 2015 Initiated: October 7, 2015 #D-0178-2016

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

Details

Units Affected
1 vial
Distribution
CA and NJ
Location
Bellflower, CA

Frequently Asked Questions

What product was recalled?
PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA. Recalled by Pacific Healthcare, Inc dba B&B Pharmacy. Units affected: 1 vial.
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-0178-2016.