Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with lack of assurance of sterility, representing a serious potential risk of contamination for patients. However, the source text does not report any illnesses, injuries, or hospitalizations, making this a precautionary recall based on manufacturing assurance concerns.
Plain-English summary
Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling Methylcobalamin 5 mg/mL, a compounded injectable form of vitamin B12. The product is supplied as multi-dose vials in 10 mL (NDC 73198-0051-10) and 30 mL (NDC 73198-0051-30) formats, for prescription use only. The recall was initiated due to lack of assurance of sterility.
Approximately 12,800 vials were affected and distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. Multiple lot numbers are affected with beyond-use dates ranging from June through July 2022.
The affected lot numbers are: L24122, L24C22, L24B22 (beyond-use date 6/22/2022), A24124-22 (7/24/2022), A24225-22 (7/25/2022), A24026-22 (7/26/2022), A24027-22 (7/27/2022), A24C31-22, and A24B31-22 (7/31/2022).
The recalled product
- 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
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sterility-failure
- contamination-risk
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distributed nationwide across the United States.
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