Drug product
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
D-0023-2017
Product summary
- Event
- Event 74816
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,547 vials
- Official record key
drug-enforcement:D-0023-2017
Official wording
Reason: CGMP Deviations
Code information: Lot # 7080315, 7400315, 7410315, 7980415
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations