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Recall Observatory FDA recall evidence

Drug product

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.

D-0275-2021

February 10, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 87298
Status
Terminated
Classification
Class II
Quantity
5,086 vials
Official record key
drug-enforcement:D-0275-2021

Official wording

Reason: 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.

Code information: Lot # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021

Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility