Recalls / Class II
Class IID-1224-2022
Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch#: 12032123A2, Exp 3/3/2022; 12102101A2, Exp 3/10/2022; 12202105A2, Exp 3/20/2022; 12292106A2, Exp 3/29/2022; 01062218B, Exp 4/6/2022; 01192228A2, Exp 4/19/2022; 01312214A2, Exp 5/1/2022; 02012211A1, Exp 5/2/2022; 02182201A1, 02182203A1, Exp 5/19/2022; 02242205A1, 02242206A1, Exp 5/25/2022; 03072209A1, Exp 6/5/2022; 03092203A1, 03092206A1, Exp 6/7/2022.
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
- 5,842 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-1224-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.