Recalls / Class II
Class IID-1213-2022
Product
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch#: a) 01172233A1, Exp 4/17/2022; 01282213A1, Exp 4/28/2022; 02192221A1, Exp 5/20/2022; b)12032118A2, Exp 3/3/2022; 12282120A2, Exp 3/28/2022 01172233A1, Exp 4/17/2022, 01282213A1, Exp 4/28/2022, 02212242A1, Exp 5/22/2022, 03042202A1, Exp 6/2/2022; c) 02192219A1, Exp 5/20/2022; 03062201A1, Exp 6/4/2022.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Moore Dr, Nicholasville, Kentucky 40356-8512
Distribution
- Quantity
- 924 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-07
- FDA classified
- 2022-07-14
- Posted by FDA
- 2022-07-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1213-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.