Compounded Semaglutide/Cyanocobalamin Vials Recalled for Sterility Concerns
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was 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 drug where sterility assurance cannot be verified. As a risk-of-harm injectable product with no reported illnesses or injuries, it meets the rubric criterion for High (3) severity.
Plain-English summary
Tailor Made Compounding is recalling Semaglutide/Cyanocobalamin 2mg/0.4mg/mL injectable vials due to a lack of assurance of sterility. The recall affects 9 vials of this compounded injectable medication (Lot #07262326A1, BUD 10/24/2023) that were distributed nationwide.
When the sterility of an injectable product cannot be assured, there is a potential risk of bacterial or fungal contamination. Such contamination could cause serious infections or other adverse health effects if the product is administered.
Consumers who have received this product should contact their healthcare provider immediately. Do not use remaining vials from the affected lot. Healthcare providers and pharmacies should quarantine any remaining vials and contact Tailor Made Compounding for return and destruction instructions.
The recalled product
- Product
- Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
- Manufacturer
- TMC Acquisitions LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- lack-of-sterility
- contamination
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)
- Lot#: 07262326A1
- BUD: 10/24/2023
Distribution
Distributed nationwide across the United States.
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