Endo USA, Inc. expanded its recall of "Clonazepam Orally Disintegrating Tablets, USP (C-IV)" on November 18th, due to "potential product carton strength mislabeling."
According to the United States Food & Drug Administration, the recalled drug in question, of which investigations are ongoing, pertains to "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."
Children and adults who consume "higher doses" of Clonazepam are at risk of "confusion, dizziness, diminished reflexes, ataxia, and hypotonia." More serious symptoms associated with consuming higher doses of the drug include "life-threatening" respiratory depression.
Clonazepam Orally Disintegrating Tablets exist as an adjunct in treating "Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures," and panic disorder.
The recalled cartons, sold in Florida, feature, "60 tablets packed into 10 blister strips each containing 6 tablets."
Health officials have already told retailers to remove the recalled products from shelves, and consumers are urged to discontinue use of the products if previously purchased.
Consumers who believe the took an incorrect dose should contact their doctor. Individuals with questions can call "855-589-1869 (Monday through Friday, 9 a.m. to 5 p.m. ET)," or email "rxrecalls@inmar.com."
View all lot numbers and photos of the recalled products on the official FDA recall page.