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FDADecember 20, 2018drug

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ

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

The hazard

Failed Dissolution Specifications

What to do

FDA enforcement status: Terminated

Brands named

amerigen pharmaceuticalsamerigen

Recall history

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

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Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ — Recall Details · AllClear