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).
- Brand
- CLONAZEPAM
- 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.
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