Anti-anxiety drug Clonazepam recalled due to potentially ‘deadly’ labeling error

Tablets of the drug clonazepam, the generic name for Klonopin, used to treat epilepsy, panic disorder and muscle spasms, have been recalled due to incorrect labeling that could inadvertently lead people to take a higher dose, potentially fatal.

Pennsylvania-based Endo, Inc. issued a nationwide voluntary recall for clonazepam orally disintegrating tablets because “a limited number of cartons” were printed with a strength and national drug code incorrect. After an investigation, the company determined that the error was made by a third-party packager.

The blister packs and tablets inside the package have the correct dosage listed, according to the press release. As of November 18, when the release was issued, the company had not received any reports of adverse reactions associated with the mislabeled drugs.

The company said in its recall notice that there is a “reasonable probability” that children and adults who inadvertently take a higher dose will suffer potentially fatal respiratory depression. This condition causes people to breathe too slowly or shallowly, which can lead to low oxygen in the blood and be potentially fatal, according to the Cleveland Clinic.

The threat of respiratory depression from mislabeled cartons is particularly acute for patients with lung disease, those prescribed close to the maximum dose, and patients taking other medications that may cause respiratory depression. additional, the company said.

Other potential side effects of accidentally taking a higher dose of the drug include significant sedation, confusion, dizziness, decreased reflexes, loss of muscle coordination, and muscle weakness.

In addition to treating anxiety and seizures, clonazepam also has unlicensed uses for restless legs syndrome, acute mania, insomnia and neurological tardive dyskinesia, which causes involuntary movements, according to the National Library of medicine.

The drugs concerned, which were distributed to pharmacies across the country, are packaged in cartons containing 60 tablets distributed in 10 blister packs each containing six tablets.

The carton and blister packs are marked with the name, strength, lot number, expiration date and NDC number. The name of the company Par Pharmaceutical, which previously marketed clonazepam before its acquisition by Endo, also appears on the packaging.

The press release includes the list of recalled products including their lot numbers. Anyone with unused tablets affected by the recall is advised to stop using them, and anyone who has inadvertently taken the wrong dose to consult a doctor.

Endo also arranged for the return of all existing stocks and informed wholesalers and retailers to stop distributing and dispensing the drug.

Consumers with questions can contact Inmar, Inc. at 855-589-1869, Monday through Friday from 9 a.m. to 5 p.m. ET, or by email at [email protected].

This article was originally published on TODAY.com