Product Safety Recalls

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Recall D-0800-2022

Description: 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

Recall D-0800-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0800-2022
Event ID89938
DistributionDistributed Nationwide in the USA
Quantity800 vials
Recall ReasonCGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Drug ClassificationClass II
Drug Code Info20220504
Recall Initiation Date20220404
Report Date20220504
Classification Date20220427
Address6700 Conroy Rd Ste 155
Orlando, FL 32835-3515
United States
Recalling FirmOlympia Compounding Pharmacy dba Olympia Pharmacy
Initial Notification Letter
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