FDAFebruary 10, 2021drug

Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

teva pharmaceuticalsteva

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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