Injectable Methylcobalamin recalled due to lack of sterility assurance
Tailor Made Compounding is recalling 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
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 with a theoretical contamination hazard due to lack of sterility assurance. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 652 vials of Methylcobalamin 10mg/mL injectable solution. The recall affects three vial sizes: 1mL, 10mL, and 30mL vials stored at room temperature. The product was distributed nationwide throughout the USA and Puerto Rico.
The recall was issued because the manufacturer cannot assure that these batches meet sterility standards. This means the product may not be free of microbial contamination.
Healthcare facilities and individuals who have these vials should stop using them and contact Tailor Made Compounding or the FDA for instructions. Affected batch numbers and expiration dates are available through the FDA. No illnesses or injuries have been reported.
The recalled product
- Product
- Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- 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 (20)
- Batch#: a)11092114A2
- Exp 4/30/2022
- 12172113A2
- Exp 6/15/2022
- 03072227A1
- Exp 9/3/2022
- b)10122101A2
- Exp 4/10/2022
- 12022116A1
- Exp 5/31/2022
- 12292115A1
- Exp 6/27/2022
- 02222207A1
- Exp 8/21/2022
- c)10112103A2
- Exp 4/9/2022
- 11192112A2
- Exp 5/18/2022
- 12142114A2
- Exp 6/12/2022
Distribution
Distributed nationwide across the United States.
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