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 Onl
Recalled May 4, 2022 · FDA recall D-0800-2022 · Olympia Compounding Pharmacy
Hazard
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated · FDA Class II
Units
800 vials
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Product
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
Manufacturer(s)
Olympia Compounding Pharmacy dba Olympia Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →