Olympia Compounding Pharmacy dba Olympia Pharmacy: Drug Recall

Recall #D-0814-2022 · 04/04/2022

Class II: Risk

Recall Details

Recall Number
D-0814-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Status
Terminated
Date Initiated
04/04/2022
Location
Orlando, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2201 vials

Reason for Recall

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

Product Description

RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by Olympia Compounding Pharmacy dba Olympia Pharmacy

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.