Drug 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.
D-0622-2024
Product summary
- Event
- Event 94945
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8,139 cartons
- Official record key
drug-enforcement:D-0622-2024
Official wording
Reason: 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.
Code information: Lot 550147301, Exp. 08/31/2026
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Error