Drug product
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1203-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90 vials
- Official record key
drug-enforcement:D-1203-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 10122110A2, Exp 3/20/2022; 12062110A2, Exp 4/30/2022; 02012202A2, 02192207A1, Exp 7/31/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility