PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: August 7, 2024 Initiated: July 10, 2024 #D-0622-2024

Product Description

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.

Reason for Recall

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.

Details

Units Affected
8,139 cartons
Distribution
Nationwide in the USA and Puerto Rico
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Endo Pharmaceuticals, Inc.. Units affected: 8,139 cartons.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 7, 2024. Severity: Critical. Recall number: D-0622-2024.