D-0743-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,713 vials
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
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