Drug product
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
D-1224-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,842 vials
- Official record key
drug-enforcement:D-1224-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 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.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility