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Recall Observatory FDA recall evidence

Drug product

Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10

D-0922-2022

May 09, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 90204
Status
Completed
Classification
Class II
Quantity
1282 vials
Official record key
drug-enforcement:D-0922-2022

Official wording

Reason: Lack of assurance of sterility.

Code information: Lots: B24115-22 BUD: 8/15/2022; L24001 BUD: 6/1/2022

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