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Recall Observatory FDA recall evidence

Drug product

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

D-0731-2021

July 29, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88442
Status
Terminated
Classification
Class II
Quantity
193,845 vials
Official record key
drug-enforcement:D-0731-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021

Distribution pattern: Product was distributed Nationwide, including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility