Drug product
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
D-0008-2018
Product summary
- Firm
- United Pharmacy
- Event
- Event 78183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 268 vials
- Official record key
drug-enforcement:D-0008-2018
Official wording
Reason: CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Code information: Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations