WhichRecall
Class I — UrgentReported 2025-01-15

Clonazepam Orally Disintegrating Tablets, USP, 0.125 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#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).

Recalled by Endo USA, Inc.

Reason for Recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled

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The blister strips inside the product carton reflect the correct strength.

Recall Number
D-0179-2025
Classification
Class I
Status
Ongoing
Category
drug
Initiated
2024-11-18
Reported
2025-01-15
Distribution
Nationwide in the USA
Code Info
Lot #: 550174101, Exp. 01/31/2027.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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