FDA-Drug2024-08-07Class I
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.
Endo Pharmaceuticals, Inc.
Hazard
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.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
8,139 cartons
Manufactured in
1400 Atwater Dr, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0622-2024Don't want to check this manually?
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