Drug product
Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.
D-0278-2021
Product summary
- Event
- Event 87298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,806 vials
- Official record key
drug-enforcement:D-0278-2021
Official wording
Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Code information: Lot # 31327600B, exp. date 08/2022
Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility