Drug recall D-0178-2025

Class I Ongoing reported Jan 15, 2025

Product

Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).

Reason for recall

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

Lots and codes

Lot # 550176501, 550176601, Exp 02/28/2027.

Recall details

Recalling firm
Endo USA, Inc., Malvern, PA
Quantity
9,816 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
November 18, 2024

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