D-0282-2021 Class II Terminated
FDA drug recall D-0282-2021 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: N/A.
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
- N/A
Product Description
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.
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 # 31327725B, exp. date 02/2021 Lot # 31327906B, exp. date 03/2021