Safety Report: Par Pharmaceutical Clonazepam Orally Disintegrating Tablets recalled due to mislabeled, USA

United States

Endo, Inc. announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. The product lots were distributed through wholesale distributors to retail pharmacies nationwide in the USA.

Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.

Risk Statement: Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, diminished reflexes, ataxia, and hypotonia. There is a reasonable probability for significant, possibly life-threatening, respiratory depression, especially for patients with concomitant pulmonary disease, patients who have been prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.

The following table details the lots being added to the voluntary recall, including the lot product description and NDC number.

PRODUCT: Clonazepam ODT, USP (C-IV) 2mg
- NDC Number: 49884-310-02
- Lot #: 550176501, 550176601.

PRODUCT: Clonazepam ODT, USP (C-IV) 0.125mg
- NDC Number: 49884-306-02
- Lot #: 550174101.

PRODUCT: Clonazepam ODT, USP (C-IV) 0.25mg
- NDC Number: 49884-307-02
- Lot #: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401.


PRODUCT: Clonazepam ODT, USP (C-IV) 1mg
- NDC Number: 49884-309-02
- Lot #: 550145201, 550175901, 550176001, 550176201.

Package Identification: The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number.

Distributors and retailers that have the product lot being recalled should immediately stop distributing and return to the place of purchase. Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product and return them to where they purchased it.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Endo, Inc.
Brand name: Par Pharmaceutical
Product recalled: Clonazepam Orally Disintegrating Tablets, USP (C-IV)
Reason for the recall: Mislabeled with the incorrect strength on the carton
FDA Recall date: November 19, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential