Drug product
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
D-0272-2021
Product summary
- Event
- Event 87298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,577 vials
- Official record key
drug-enforcement:D-0272-2021
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 # 31326669B, exp. date 03/2021
Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility