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Recall Observatory FDA recall evidence

Drug product

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

D-0376-2021

April 26, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 87875
Status
Terminated
Classification
Class II
Quantity
7,564/1 multiple dose vial per carton
Official record key
drug-enforcement:D-0376-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # 31327989B, exp. date 04/2021

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility