People who suffer from anxiety or panic attacks should be aware of this warning. Endo Pharmaceuticals has issued a nationwide clonazepam recall. The drug is considered mislabeled, putting the user at risk of overdose. Patients are advised to stop using the recalled medication and consult with their doctor.
Widespread Clonazepam Recall Details
Endo Pharmaceuticals, a Pennsylvania-based drug company, has expanded the recall of its Clonazepam Orally Disintegrating Tablets throughout the United States. The recall affects 16 lots with doses ranging from 0.125 mg to 2 mg and expiration dates between August 2026 and February 2027. Mislabeling issues have resulted in incorrect dosage indications, endangering lives, according to Endo.
Clonazepam, a benzodiazepine, is frequently used to treat panic attacks and certain types of seizures. The labeling error could lead to higher intake than recommended, increasing the risk of serious side effects like sleepiness, dizziness, confusion, and respiratory distress. While no harm has been reported, the possibility of overdose remains concerning.
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
Previous Recall and Current Actions
The initial recall in July focused on a specific lot with a mislabeling error attributed to a “error at a third-party packager,” with cartons indicating an incorrect strength of 0.125 mg rather than 0.25 mg. The expanded recall now aims to prevent unintentional patient exposure to inappropriate dosages by recalling all suspect lots. If exposed to potentially incorrect doses, patients should immediately discontinue use and seek medical advice.
Par Pharmaceutical of New York distributes the cartons affected by the recall. Medical professionals advise retailers to remove these products from shelves immediately and collaborate with suppliers to ensure consumer safety. Questions or concerns about the recall can be directed to (855) 589-1869 or [email protected].
Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton https://t.co/JxLaxUQGfJ pic.twitter.com/iENv85ZjLU
— U.S. FDA Recalls (@FDArecalls) July 17, 2024
Precautionary Advice for Consumers and Retailers
To avoid dosing errors, people who use clonazepam for anxiety or seizures should double-check the batch number on their medication. Health officials emphasize the importance of consulting with healthcare providers if there is a suspicion of dosage error. As Endo navigates this massive recall operation, the primary goal remains to reduce risks and protect the health of those who may be affected by this drug labeling issue.
The company assures that no adverse effects have been reported, but emphasizes the importance of caution moving forward. This recall is a stark reminder of pharmaceutical companies’ responsibilities to maintain product integrity and protect public health.
Sources:
- Popular anxiety drug being recalled nationwide for ‘possibly life-threatening’ error
- Anxiety drug recalled over ‘life-threatening’ label mistake