Drug product
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0743-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,713 vials
- Official record key
drug-enforcement:D-0743-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) 31329363B, exp. date 01/2022; 31329484B, exp. date 03/2022 b) 31328367B, 31328431B, exp. date 07/2021; 31329014B, exp. date 11/2021
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility