Nationwide Recall of Anxiety Drug Over Packaging Error

The drug clonazepam, used to treat anxiety, seizures and muscle spasms, is being recalled over a potentially fatal mislabeling mistake.

Endo Inc., based in Pennsylvania, has announced a voluntary recall of 16 lots of Clonazepam Orally Disintegrating Tablets after it discovered that a number of cartons may have been printed with the incorrect strength and National Drug Code (NDC) on them.

Children and adults prescribed these drugs could mistakenly be taking the wrong dose as a result, putting them at risk of unpleasant and dangerous side effects.

These side effects could include significant sedation, confusion, dizziness, diminished reflexes, ataxia—where balance, coordination and speech become less controlled—and hypotonia, also known as low muscle tone or floppy muscle syndrome.

Endo stated on their website: “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.”

Respiratory depression is a condition where breathing becomes slow, shallow or ineffective, and can be fatal.

Clonazepam is prescribed to treat seizure disorders, such as epilepsy, panic disorder—a form of anxiety where an individual suffers frequently from panic attacks—and other complaints, such as restless leg syndrome or muscle spasms.

It works by increasing the levels of gamma-aminobutyric acid (GABA), a calming chemical, in the brain, which can relieve anxiety, stop seizures and relax tense muscles.

As of this Monday, Endo had not received any reports of adverse events in relation to this recall.

The recalled products were distributed to pharmacies nationwide, packaged in cartons containing 60 tablets packed into 10 blister strips of six tablets.

The carton, and each blister strip pocket, are labeled with the drug’s name, strength, lot number, expiration date and NDC number, as well as the brand name “Par Pharmaceutical,” which sold clonazepam before it was acquired by Endo.

Individuals who have some unused clonazepam with the recalled lot numbers on its packaging are being advised to stop taking it. Anyone who may have taken the incorrect dose by mistake should talk to their doctor.

Distributors and retailers with the recalled products should immediately stop distributing and selling them.

Endo is working with a company called Inmar Inc. to arrange for the return of recalled products, via the telephone number 855-589-1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) and email address rxrecalls@inmar.com.

This mislabeling issue was identified by Endo during an ongoing investigation by the company and is believed to be due to an error made by a third-party packager.

Endo announced the expansion of its voluntary recall on Monday, November 18, and the U.S. Food and Drug Administration followed suit on the next day.

Newsweek has approached Endo for comment via email.

Other ongoing recalls include cinnamon recalled due to potential lead contamination, ice cream recalled due to incorrect allergy labeling and carrots implicated in a deadly E. coli outbreak.

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