Drug product
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
D-0735-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62,358 vials
- Official record key
drug-enforcement:D-0735-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31325960B, exp. date12/2021; 31326111B, exp. date 01/2022; 31326875B, exp. date 03/2022; 31326915B, exp. date 03/2022; 31326916B, 31326917B, exp. date 04/2022; 31329079B, exp. date 04/2023; 31329085B, exp. date 05/2023
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility