Cyanocobalamin Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
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 FDA Class II recall involves a compounded injectable medication lacking sterility assurance, which is a risk-of-harm product. No illnesses or injuries have been reported, placing it at High severity per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1282 vials of Cyanocobalamin 2 mg/mL injection. The recalled product includes Lot B24115-22 (Beyond Use Date 8/15/2022) and Lot L24001 (Beyond Use Date 6/1/2022).
The recall was initiated due to lack of assurance of sterility. Sterile products must meet specific standards to ensure they are free from microorganisms, and this recall indicates the manufacturer could not provide assurance that this standard was met.
The affected vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. Healthcare providers and patients who have received or possess affected vials should cease use and contact their healthcare provider or the manufacturer for further guidance.
The recalled product
- 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
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance-failure
- contamination-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 (2)
- Lots: B24115-22 BUD: 8/15/2022
- L24001 BUD: 6/1/2022
Distribution
Distributed nationwide across the United States.
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