Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 table
Summary
The FDA issued a Class I for Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per car by Endo Pharmaceuticals, Inc.. 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 produc.
Details
Source
Drug Recall
External ID
D-0622-2024
Action Date
2024-08-07
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot 550147301, Exp. 08/31/2026
Quantity Affected: 8,139 cartons
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.
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-10
Company
Malvern, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Endo Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Endo Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Endo Pharmaceuticals, Inc. have FDA actions?
Endo Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0622-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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