A popular medication used to treat anxiety has been recalled around the country — including Tennessee — due to a serious "mislabeling" error that poses a potentially "life-threatening" risk.
Endo USA, Inc. expanded its voluntary recall of "Clonazepam Orally Disintegrating Tablets, USP (C-IV)" over a "potential product carton strength mislabeling," according to a recall notice shared by the U.S. Food & Drug Administration. The recall affects several lot numbers that feature an incorrect strength and NDC code due to an error made by a third-party packager.
The products, which include doses ranging from 0.125 milligrams to 2 milligrams, were packaged in cartons of 60 tablets, with 10 blister strips containing six tablets each. The FDA notes that the blister strips and tablets feature the correct strength while the carton is mislabeled. Find a full list of product descriptions, NDC numbers and lot numbers on the FDA's website.
Clonazepam is a benzodiazepine used to treat certain seizures as well as panic disorder, and the mislabeled strength could cause consumers to take a higher dose which could lead to "significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia" as well as "possibly life-threatening" respiratory issues.
Anyone with the affected product is urged to discontinue use immediately, and those who inadvertently took an incorrect dose should consult their doctor. As of time of the recall, no adverse events have been reported in connection to the labelling error.
For more information about the recall, visit fda.gov.