FDAApril 4, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

olympia compounding pharmacy dba olympia pharmacyolympiaolympia compounding

UPCs

73198000410

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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