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FDAJuly 10, 2024drug

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

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

The hazard

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

What to do

FDA enforcement status: Terminated

Brands named

endo pharmaceuticalsendo

Recall history

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

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