Recall
FDAHealthNovember 18, 2024

Endo USA, Inc. — 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, Chestnu

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 18, 2024

Nationwide in the USA

What's affected?

Product
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).
Lot code
550174101

Additional details

Lot #: 550174101, Exp. 01/31/2027.

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 8,029 cartons.

View original FDA notice →

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