Drug product
MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
D-0275-2021
Product summary
- Event
- Event 87298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,086 vials
- Official record key
drug-enforcement:D-0275-2021
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 # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021
Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility