FDA

Endo issues expanded recall for clonazepam over strength mislabeling

November 25, 2024

Endo USA, Inc. has expanded its voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential mislabeling of product carton strength. The recall is due to some cartons being printed with incorrect strength and National Drug Code (NDC) codes, although the blister strips and tablets inside reflect the correct strength.

Clonazepam is used for treating Lennox-Gastaut syndrome, akinetic and myoclonic seizures, and panic disorder. The mislabeled products were distributed nationwide through wholesale distributors to retail pharmacies.

The images below provide an example of the potential mislabeling, showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam Orally Disintegrating Tablets, USP 1 mg 60-count. Distributors and retailers are advised to stop distributing and to return the affected lots, while consumers should discontinue use and consult their physician if they have the recalled product.

Source:

FDA. (2024, November 19). Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential