D-0275-2021 Class II Terminated
FDA drug recall D-0275-2021 was initiated by Teva Pharmaceuticals USA on February 10, 2021 and is designated Class II. Reason for recall: 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 pr… The recall status is terminated (terminated May 15, 2024). Affected quantity: 5,086 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- February 10, 2021
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,086 vials
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Code Information
Lot # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021