TOPIC: Clonazepam Orally Disintegrating Tablets USP by Endo: Recall Expansion - Due to Potential Product Carton Strength Mislabeling
AUDIENCE: Patient, Health Care Professional, Neurology, Psychiatry
ISSUE: Endo USA is expanding its previously announced recall of Clonazepam Orally Disintegrating Tablets USP due to potential product carton strength mislabeling.
Specifically, Endo’s ongoing investigation has identified the possibility that the affected clonazepam product lot numbers contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.
Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
The product lots were distributed through wholesale distributors to retail pharmacies nationwide.
To date, Endo has not received any reports of adverse events associated with this product recall.
For more information about this recall, including the affected clonazepam product lot numbers, click on the red button "Read Recall" below.
BACKGROUND: Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.
RECOMMENDATIONS:
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Patients in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating Tablets USP bearing the affected lot numbers have been advised to discontinue use of the product.
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In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician.
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Patients with questions regarding this recall can contact Inmar by telephone at 855-589- 1869 or by email at rxrecalls@inmar.com.
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For more information about Clonazepam Orally Disintegrating Tablets USP, please see full Prescribing Information including BOXED WARNING available at DailyMed - CLONAZEPAM tablet, orally disintegrating (nih.gov).
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Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc.
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Distributors and retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar.
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