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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.

D-0912-2022

May 09, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 90204
Status
Completed
Classification
Class II
Quantity
33 vials
Official record key
drug-enforcement:D-0912-2022

Official wording

Reason: Lack of assurance of sterility.

Code information: Lot: J24B13 BUD: 10/13/2022

Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility