FDA-Drug2015-11-18Class II

PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Pacific Healthcare, Inc dba B&B Pharmacy
Hazard

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

Sold states
CA and NJ
Affected count
1- 5ml vial, 1- 10 ml vial
Manufactured in
10244 Rosecrans Ave, N/A, Bellflower, CA, United States
Products
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2016

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