Olympia Compounding Pharmacy dba Olympia Pharmacy: Drug Recall

Recall #D-0799-2022 · 04/04/2022

Class II: Risk

Recall Details

Recall Number
D-0799-2022
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
6916 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

T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .

Distribution Pattern

Distributed Nationwide in the USA

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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.