Drug product
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
D-0279-2021
Product summary
- Event
- Event 87298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,6697 vials
- Official record key
drug-enforcement:D-0279-2021
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 # 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022
Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility