Endo Pharmaceuticals has issued a nationwide recall on its clonazepam tablets due to a mislabeling error that could pose serious health risks.
At a Glance
- Endo is recalling clonazepam tablets for mislabeling, impacting drug strength and code.
- The recall affects 16 lots with doses from 0.125 mg to 2 mg.
- Potential risks include respiratory issues, confusion, and dizziness.
- No adverse events have been reported yet.
Recall Details and Potential Risks
Pennsylvania-based Endo Pharmaceuticals is expanding its recall of clonazepam tablets. The mislabeling affects drug strength and code on cartons. Clonazepam, a benzodiazepine used for panic disorders and seizures, is being recalled in 16 lots, with doses ranging from 0.125 mg to 2 mg. Incorrect labeling might cause overdoses, leading to symptoms like drowsiness, confusion, and significant breathing difficulties. Consumers should check their medication and consult their healthcare provider if affected.
No harm has been reported thus far for this recall, which also included Par Pharmaceutical of New York listed as the distributor on some cartons. It is crucial for anyone who suspects they might have taken an incorrect dose to stop immediately and speak with their doctor. Retailers are urged to remove these products from their shelves, ensuring they are not sold to unaware consumers.
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
History of the Recall
The initial recall began in July 2024 after an error was identified at a third-party packager. An example of the issue was cartons that incorrectly indicated a strength of 0.125 mg rather than 0.25 mg. With this expanded recall, Endo aims to rectify any potential health risks associated with the mislabeling. They urge consumers to remain vigilant and contact them directly for more information or support via phone at (855) 589-1869 or by email at [email protected].
The decision to recall a medication, particularly one widely used like clonazepam, is significant. This recall provides a prime example of the far-reaching implications that packaging and labeling errors can have on the pharmaceutical industry and patient safety. The Food and Drug Administration frequently updates its recall list, and consumers are encouraged to stay informed on such matters.
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
Ensuring Consumer Safety
Endo Pharmaceuticals aims to ensure consumer safety with this recall. This measure highlights the necessity for manufacturers to maintain stringent quality checks in pharmaceutical production and packaging processes. While the current status indicates no adverse incidents, ongoing monitoring will be critical to protect public health. Consumers with questions or concerns about clonazepam are advised to contact their healthcare provider without delay.
As the recall continues, patients and pharmacists must remain vigilant to avoid potential health complications resulting from mislabeled medication. Keeping informed through reliable sources will help consumers take appropriate actions concerning their prescriptions.
Source:
Popular anxiety drug being recalled nationwide for ‘possibly life-threatening’ error
