Recalls / Class II
Class IID-1214-2022
Product
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
- Affected lot / code info
- 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, Exp 6/1/2022
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
- 232 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-1214-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.