Recalls / Class II
Class IID-0936-2022
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
- Affected lot / code info
- 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
Why it was recalled
Lack of assurance of sterility.
Recalling firm
- Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6700 Conroy Rd Ste 155, Orlando, Florida 32835-3515
Distribution
- Quantity
- 12800 vials
- Distribution pattern
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Timeline
- Recall initiated
- 2022-05-09
- FDA classified
- 2022-05-25
- Posted by FDA
- 2022-06-01
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0936-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.