Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
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 of a compounded injectable medication due to lack of sterility assurance. This represents a risk-of-harm product where injection of non-sterile material could result in serious infections, although no illnesses have been reported at this time.
Plain-English summary
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable solution, available in 10 mL and 30 mL vials at room temperature. Multiple batch numbers are affected, with expiration dates ranging from March 2022 through June 2022.
The recall was issued due to lack of assurance of sterility. Sterile injectables are essential to prevent potential infections when medications are administered to patients.
The recalled product was distributed nationwide throughout the United States and Puerto Rico. Healthcare providers and patients who received this product should discontinue its use immediately.
Individuals who have been treated with this medication should contact their healthcare provider for guidance. Healthcare providers can obtain additional information about the specific affected batch numbers from the FDA or Tailor Made Compounding.
The recalled product
- Product
- Methionine/Inositol/Choline B12 25mg/50mg/50mg/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 Injectable
- Hazard
- lack-of-sterility
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 (14)
- Batch#: a) 12092105A2
- exp 3/9/2022
- 01042219A2
- Exp 4/4/2022
- 01202210A2
- exp 4/20/2022
- 01282207A1
- exp 4/28/2022
- 03032217A1
- Exp 6/1/2022
- 12092105A2
- b) 01282207A1
- Exp 4/28/2022
- 03032241A1
Distribution
Distributed nationwide across the United States.
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