Endo Pharmaceuticals has issued a nationwide recall of their Clonazepam due to potentially dangerous mislabeling.
At a Glance
- Endo Pharmaceuticals recalls mislabelled clonazepam tablets.
- Clonazepam is a benzodiazepine for anxiety and seizures.
- Recall impacts 16 lots; overdose risks can be severe.
- No adverse incident reports yet; retailers advised to remove stock.
Overview of the Recall
Endo Pharmaceuticals, a Pennsylvania-based drug maker, is recalling Clonazepam Orally Disintegrating Tablets due to incorrect drug strength labeling and wrong drug codes on cartons. The recall affects 16 lots, with doses ranging from 0.125 mg to 2 mg. Tablets in these lots are set to expire between August 2026 and February 2027. As of now, no adverse incidents have been reported, and consumers are advised to consult healthcare professionals if the medication has been ingested and poses any concerns.
The recall was initially announced on July 16 and publicly disseminated a day later. Mislabeling was attributed to a packaging error by a third-party distributor, with incorrect strength labeling on cartons that list Par Pharmaceutical as the distributor. Par marketed clonazepam before Endo’s acquisition.
Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling https://t.co/6oqclPQZOT pic.twitter.com/f3OJATXeCL
— U.S. FDA Recalls (@FDArecalls) November 19, 2024
Potential Risks and Safety Precautions
Consuming a higher dose than prescribed can lead to side effects such as increased sleepiness, confusion, dizziness, diminished reflexes, and muscle control loss, with more severe potential outcomes like breathing difficulties. The issue is particularly concerning for vulnerable populations, including children and those with pulmonary diseases. To mitigate risks, consumers should check their medications and stop using recalled products immediately. Pharmacists should be contacted for replacement options.
“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,” Endo stated on their website.
Treatments with clonazepam belong to the benzodiazepine group of medications, known for alleviating anxiety and certain seizures. These medications work by increasing gamma-aminobutyric acid (GABA) levels in the brain, which helps calm the nervous system.
Some packages of clonazepam, a prescription medication used to treat seizures and anxiety, were mislabeled with the incorrect strength and have been added to a voluntary recall, according to the FDA. https://t.co/b9eO1bkt73
— ABC News (@ABC) November 22, 2024
Next Steps for Consumers and Retailers
Retailers and wholesalers have been directed to pull affected stock from circulation and inform any potentially affected consumers. Endo Pharmaceuticals is coordinating the return of recalled products with Inmar Inc. Consumers who have taken these tablets should consult a medical professional and report any adverse reactions to the FDA. For disposal assistance, consumers can contact MedWaste Management.
For those needing further information about the recall or how to proceed, contact methods provided include calling (855) 589-1869 or emailing [email protected]. Vigilance and responsible management can significantly reduce the risks associated with this recall.
