PAPA/PGE1/PHENTO Injection recalled over sterility concerns

Recall date

October 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0174-2016

FDA classification

Class II

Brand / firm

Pacific Healthcare, Inc dba B&B Pharmacy

Sold / distributed

CA and NJ

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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