Clonazepam Orally Disintegrating Tablets recall

Why it was recalled

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.

Details

Product

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.

Recalling company

Endo Pharms

Classification

Class I

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA and Puerto Rico

Initiated

Jul 10, 2024

FDA report date

Aug 7, 2024