MALVERN, PA – Endo, Inc. (OTCQX: NDOI) has expanded its voluntary recall of certain Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential mislabeling on product cartons. The affected lots, listed below, may contain cartons printed with incorrect strength and National Drug Code (NDC) information, resulting from a third-party packaging error. The blister strips and tablets inside the cartons, however, are correctly labeled.
Affected Lots and Products
- Clonazepam ODT 2mg
Lot Numbers: 550176501, 550176601 - Clonazepam ODT 0.125mg
Lot Number: 550174101 - Clonazepam ODT 0.25mg
Lot Numbers: 550142801 through 550143401, 550147201, 550147401 - Clonazepam ODT 1mg
Lot Numbers: 550145201, 550175901, 550176001, 550176201
Potential Risks
Incorrect labeling could lead to accidental overconsumption, putting children and adults at risk of severe adverse reactions such as sedation, confusion, dizziness, diminished reflexes, and serious respiratory depression. Patients with underlying respiratory conditions or those taking high doses or other sedatives face an increased risk of life-threatening complications.
Fortunately, no adverse events related to this recall have been reported to date.
Product Information
Clonazepam Orally Disintegrating Tablets are typically prescribed to treat Lennox-Gastaut syndrome (a form of epilepsy), akinetic and myoclonic seizures, and panic disorders. The tablets are sold in cartons containing 60 tablets, divided into 10 blister strips of six tablets each. Both the cartons and blister strips are labeled with the name, strength, lot number, expiration date, and NDC.
Next Steps for Distributors and Consumers
Distributors and retailers have been instructed to remove the affected lots from shelves immediately and arrange for return through Endo’s designated partner, Inmar, Inc. Consumers are advised to stop using the products if they match the lot numbers above and consult their healthcare provider if they have taken an incorrect dose.
For questions about this recall, consumers can contact Inmar at 855-589-1869, Monday to Friday, 9 a.m. to 5 p.m. ET, or via email at rxrecalls@inmar.com.
Adverse reactions or quality issues can also be reported to the FDA’s MedWatch program through their website, by mail, or by fax at 1-800-FDA-0178.
This recall, carried out with the FDA’s knowledge, aims to prevent any potential health risks and ensure the safety of patients who rely on the medication.
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