Methylcobalamin 1mg/mL Vials Recalled for Lack of Sterility Assurance
TMC Acquisition LLC recalls 191 vials of Methylcobalamin 1mg/mL distributed nationwide and in Puerto Rico due to lack of sterility assurance. Consult your healthcare provider regarding any vials in your possession.
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: FDA Class II recall for pharmaceutical product with lack of sterility assurance. No adverse events are mentioned in the recall notice. The hazard is assurance-based (potential contamination) rather than confirmed contamination or reported illnesses, supporting a High severity classification.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 191 vials of Methylcobalamin 1mg/mL due to lack of assurance of sterility. The recalled product includes 10 mL and 30 mL vials distributed nationwide and in Puerto Rico. Specific batch numbers affected are 10282106A1, 11022118A1, 12292115A1, 12082113A2, and 03072230A1, with expiration dates ranging from April through September 2022.
The recall was issued because the manufacturer cannot provide assurance that the product is sterile.
Consumers who have purchased or received any of the recalled vials should stop using them and contact their healthcare provider or pharmacy. Healthcare providers and pharmacies should quarantine affected batches and contact the manufacturer or FDA for return instructions.
The recalled product
- Product
- Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Medication
- Hazard
- lack-of-sterility
- 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 (10)
- Batch #: a) 10282106A1
- Exp 4/26/2022
- 11022118A1
- Exp 4/30/2022
- 12292115A1
- Exp 6/27/2022
- b)12082113A2
- Exp 6/2/2022
- 03072230A1
- Exp 9/3/2022.
Distribution
Distributed nationwide across the United States.
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