Drug product
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
D-1204-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 Vials
- Official record key
drug-enforcement:D-1204-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 10122105A2, Exp 3/20/2022; 01182216A1, Exp 5/31/2022; 02192207A1, Exp 7/31/2022; 03072206A1, Exp 9/3/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility