A widely prescribed anti-anxiety drug, Clonazepam, has been voluntarily recalled due to a labeling error that could lead to potentially life-threatening consequences. The recall, announced by the U.S. Food and Drug Administration (FDA), affects 16 lots of Clonazepam Orally Disintegrating Tablets distributed nationwide.
What Happened?
Pharmaceutical company Endo Inc. issued the recall after discovering that cartons of the anti-anxiety drug were mislabeled with incorrect dosage strengths and National Drug Codes (NDCs). This error was attributed to a third-party packaging company. The affected products were distributed in cartons containing 60 tablets divided into 10 blister strips, each holding six tablets.
While the blister packs themselves have the correct dosage printed on them, the mislabeled outer cartons could result in patients taking incorrect doses. The FDA warns that this mistake could lead to significant risks, especially for those with pre-existing pulmonary conditions or those on near-maximum prescribed doses of Clonazepam.
Health Risks
Clonazepam, a drug from the benzodiazepine class, is typically used as an anti-anxiety pill, or for seizures and panic disorders. It works by calming the nervous system, but even small deviations in dosage can have severe effects. The FDA noted that incorrect dosages could cause symptoms such as:
- Significant sedation
- Confusion and dizziness
- Loss of reflexes (ataxia)
- Muscle weakness (hypotonia)
The most severe consequence is respiratory depression, a condition where breathing slows to dangerously low levels, potentially leading to life-threatening oxygen deprivation. This risk is particularly acute for patients with existing pulmonary disease or those taking medications that can compound respiratory suppression.
What Patients Should Do
Consumers with affected cartons are advised to discontinue use immediately and consult their healthcare provider if they suspect they’ve taken an incorrect dose. Retailers and distributors have been instructed to halt the sale and distribution of the affected lots and return the products to the supplier.
Patients and healthcare professionals can refer to the FDA’s recall notice for a detailed list of affected lot numbers. For assistance, the recall is being managed by Inmar Inc., which can be reached at 855-589-1869 or via email at [email protected].
Endo Inc. has stated that, as of November 21, there have been no reported adverse reactions related to the mislabeled products. However, the company has emphasized the importance of immediate action to mitigate risks.
This anti-anxiety drug recall highlights the critical need for vigilance in medication packaging and the serious consequences labeling errors can pose. Patients are urged to check their prescriptions and act promptly to avoid any potential health risks.
Read More: Costco Had to Recall Nearly 80,000lbs of Butter For The Most Hilarious Reason