Drug product
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
D-0733-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,712 vials
- Official record key
drug-enforcement:D-0733-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31329243B, exp. date 05/2022
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility