Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6…
- Recall date
- November 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0178-2025
- FDA classification
- Class I
- Brand / firm
- Endo USA, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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).
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