Recalls / Class II
Class IID-1225-2022
Product
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch#: 12092115A2, Exp 3/9/2022; 12162116A2, Exp 3/16/2022; 12212106A2, Exp 3/21/2022; 01062219B, Exp 4/6/2022; 01072205A1, 01072208A1, Exp 4/7/2022; 01102203A1, Exp 4/10/2022; 01132207A1, Exp 4/13/2022; 01192216A1, Exp 4/19/2022; 01202204A2, Exp 4/20/2022; 01272223A2, Exp 4/27/2022; 01312219A2, Exp 5/1/2022; 02032204A2, Exp 5/4/2022; 02072203A1, Exp 5/8/2022; 02182216A1, 02182224A1, Exp 5/19/2022; 02232202A1, 02232210A1, Exp 5/24/2022; 02242202A1, 02242203A1, 02242235A1, 02242238A1, Exp 5/25/2022; 03072217A1, 03072223A1, Exp 6/5/2022; 03082223A1, 03082229A1, Exp 6/6/2022; 03092207A1, 03092219A1, 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
- 9,993 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-1225-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.