Clonazepam Recalled Nationwide Over Potentially Life-Threatening Labeling Error
Pharmaceutical company Endo, Inc. has expanded its recall of the anxiety and seizure medication due to mislabeled dosage strength and drug codes.
- The U.S. FDA has announced a nationwide recall of 16 lots of Clonazepam Orally Disintegrating Tablets due to mislabeled packaging that could lead to incorrect dosing.
- The labeling error, caused by a third-party packager, affects the dosage strength and National Drug Code printed on the cartons, though the blister strips inside are correctly labeled.
- Taking an incorrect dose of clonazepam may result in severe side effects, including sedation, confusion, dizziness, and potentially life-threatening respiratory depression, particularly for vulnerable patients.
- Endo, Inc., the manufacturer, has reported no adverse events linked to the mislabeled products as of November 21, 2024, and advises consumers to discontinue use of affected lots immediately.
- Consumers and retailers are instructed to stop using or distributing the impacted products and contact Inmar, Inc. for returns or further assistance.