The recall affects several lots of clonazepam ODT in various strengths, including 2 milligram, 1 milligram, 0.25 milligram and 0.125 milligram, which were distributed to retail pharmacies nationwide, according to an Nov. 19 news release from the FDA.
The issue stems from cartons being printed with incorrect strength and National Drug Code numbers, although the blister strips and tablets inside the packaging are correct. This mislabeling could result in individuals consuming higher doses of clonazepam, increasing the risk of dangerous side effects including significant sedation, confusion, dizziness and potentially life-threatening respiratory depression.
Endo has not received any reports of adverse events associated with the recalls. Consumers with the affected product are urged to discontinue use immediately and consult a healthcare provider.
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