Formula F9 recalled over manufacturing violations

Recall date

April 4, 2022

Source

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

Official notice title

Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx On…

Recall number

D-0800-2022

FDA classification

Class II

Brand / firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

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

What was recalled

Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10