Drug 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).
D-0178-2025
Product summary
- Firm
- Endo USA, Inc.
- Event
- Event 95778
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 9,816 cartons
- Official record key
drug-enforcement:D-0178-2025
Official wording
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Code information: Lot # 550176501, 550176601, Exp 02/28/2027.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Error