Medical Professionals Reference (MPR)More Clonazepam ODT Recalled Due to Carton Strength Mislabeling

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Endo has expanded its recall of Clonazepam Orally Disintegrating Tablets (ODT) to include multiple lots due to carton strength mislabeling. The recall affects various strengths of the medication, from 0.125mg to 2mg, distributed nationwide through wholesalers to retail pharmacies. Although the blister strips contain correct labeling, the cartons may display incorrect strength or National Drug Code (NDC) information.

Key Points:

• The recall expansion encompasses 14 lots across four different strengths of clonazepam ODT, including 2mg, 0.125mg, 0.25mg, and 1mg formulations
• No adverse events have been reported related to this labeling error at the time of the recall notice
• Primary safety concerns include potential increased risk of sedation, dizziness, ataxia, confusion, and significant respiratory depression, particularly in patients with pulmonary disease or those taking concurrent respiratory depressants
• The medication is indicated for Lennox-Gastaut syndrome treatment and panic disorder, either as monotherapy or adjunctive therapy
• Retail pharmacies must immediately cease dispensing affected lots, with specific instructions provided for product return and reporting

HCN Medical Memo
Additional information can be obtained by calling 855-589-1869 or via email at rxrecalls@inmar.com.

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