Skip to content
Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

D-0936-2022

May 09, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 90204
Status
Completed
Classification
Class II
Quantity
12800 vials
Official record key
drug-enforcement:D-0936-2022

Official wording

Reason: Lack of assurance of sterility.

Code information: Lots: L24122, L24C22, L24B22 BUD: 6/22/2022, A24124-22 BUD: 7/24/2022, A24225-22 BUD: 7/25/2022, A24026-22 BUD: 7/26/2022, A24027-22 BUD: 7/27/2022, A24C31-22, A24B31-22 BUD: 7/31/2022

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