Recalls / Class II
Class IID-1196-2022
Product
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch #: 11022106A1, Exp 4/30/2022; 11192106A2, Exp 5/18/2022; 12022105A1, Exp 5/31/2022; 12132108A1, Exp 6/11/2022; 12292117A1, Exp 6/27/2022.
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
- 180 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-1196-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.