D-0376-2021 Class II Terminated

Recalled by Teva Pharmaceuticals USA — Parsippany, NJ

FDA drug recall D-0376-2021 was initiated by Teva Pharmaceuticals USA on April 26, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2024). Affected quantity: 7,564/1 multiple dose vial per carton.

Recall Details

Product Type
Drugs
Report Date
May 26, 2021
Initiation Date
April 26, 2021
Termination Date
June 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,564/1 multiple dose vial per carton

Product Description

Methylprednisolone Acetate Injectable Suspension USP, 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

Distribution Pattern

Product was distributed nationwide.

Code Information

Lot # 31327989B, exp. date 04/2021