FDAHealthJuly 10, 2024
Endo Pharmaceuticals, Inc. — Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutic
⚠️ Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 10, 2024
Nationwide in the USA and Puerto Rico
What's affected?
- Product
- Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
- Brand
- CLONAZEPAM
- Lot code
- 550147301
Additional details
Lot 550147301, Exp. 08/31/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 8,139 cartons.
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