The drug clonazepam, used to treat anxiety, seizures and muscle spasms, is being recalled due to a potentially fatal mislabeling error.
Pennsylvania-based Endo Inc. is voluntarily recalling 16 lots of clonazepam orally disintegrating tablets after it was discovered that a number of cartons may have incorrect strengths and National Drug Codes (NDCs) printed on them. announced.
Children and adults prescribed these drugs may end up accidentally taking the wrong dose, putting them at risk for unpleasant and dangerous side effects.
These side effects include significant sedation, confusion, dizziness, decreased reflexes, ataxia that causes difficulty in balance, coordination, and speech control, and hypotonia, also known as hypotonia or floppy muscle syndrome. There is a possibility that
Dr. Endo says on his website: “Especially in patients with concomitant pulmonary disease, those prescribed doses near the maximum dose, and other medications that may cause additional respiratory depression. There is a good chance that severe, possibly life-threatening respiratory depression will occur in patients taking this drug. ”
Respiratory depression is a condition in which breathing becomes slow, shallow, or ineffective and can be fatal.
Clonazepam is prescribed to treat seizure disorders such as epilepsy, panic disorder (a type of anxiety disorder in which individuals suffer from frequent panic attacks), and other conditions such as restless leg syndrome and muscle spasms.
It works by increasing levels of gamma-aminobutyric acid (GABA), a calming chemical in the brain, which can relieve anxiety, stop seizures, and relax tense muscles.
As of Monday of this week, Endo has not received any reports of adverse events related to this recall.
The recalled product was packaged in cartons containing 60 tablets, packed in 10 blister strips of six tablets, and distributed to pharmacies across the country.
The carton and the pockets of each blister strip list the drug’s name, strength, lot number, expiration date, NDC number, as well as the brand name “Par Pharmaceutical” under which clonazepam was sold prior to Endo’s acquisition .
Anyone in possession of unused clonazepam with recalled lot numbers on the packaging is advised to stop taking it. Anyone who may have accidentally taken the wrong dose should consult their doctor.
Distributors and retailers with recalled products must immediately stop distributing and selling them.
Mr. Endo is working with a company called Inmar Inc. to report recalled products via phone number 855-589-1869 (Monday through Friday, 9am to 5pm ET) and email address [email protected] We are arranging the return of the item.
Rattankhun Thongbun/Getty Images
This mislabeling issue was identified by Endo during an ongoing investigation by the company and is believed to be caused by an error by a third-party packager.
Endo announced an expanded voluntary recall on Monday, November 18th, and the U.S. Food and Drug Administration followed suit the next day.
newsweek Mr. Endo reached out to Endo for comment via email.
Other ongoing recalls include cinnamon recalled due to possible lead contamination, ice cream recalled due to false allergy labeling, and carrots implicated in a deadly E. coli outbreak.
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