Recall
FDAHealthNovember 18, 2024

Endo USA, Inc. — 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 Ridg

⚠️ 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 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).
Lot code
550176501

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 9,816 cartons.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.