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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0823-2022

April 04, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 89938
Status
Terminated
Classification
Class II
Quantity
7161 vials
Official record key
drug-enforcement:D-0823-2022

Official wording

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

Code information: Lots: a) D48027 BUD: 4/27/2022,E47017 BUD: 5/17/2022, F42007 BUD: 6/7/2022, F42107 BUD: 6/7/2022, F42207 BUD: 6/7/2022, F48009 BUD: 6/9/2022, F48109 BUD: 6/9/2022, H47003 BUD: 8/3/2022; b) F24024 BUD: 6/24/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations