FDA: Common Anxiety Drug Being Recalled Over ‘Possibly Life-Threatening’ Mislabeling

A pharmaceutical company expanded its prior recall of anti-anxiety drug clonazepam tablets due to a potential “mislabeling” about the product’s strength on its carton that could be “life-threatening,” according to an announcement published by the U.S. Food and Drug Administration (FDA).
In the notice updated Nov. 19, Endo Inc. said that the impacted products, already under recall, are Clonazepam Orally Disintegrating Tablets, USP.
An ongoing investigation initiated by the firm shows there is a chance more impacted product lots “contain a limited number of cartons printed with the incorrect strength” and incorrect National Drug Code because of “an error by a third-party packager,” it said.
The clonazepam was packaged by Par Pharmaceutical before the drug was acquired by Endo, according to the notice.
“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.”
But so far, the company said it has not received any reports of adverse reactions from the recalled drugs.
The recalled Endo-made clonazepam lots contain 60 tablets packed into 10 blister strips that each contain 6 tablets. The blister strip pocket and carton also have the name, lot number, strength, NDC number, and expiration date printed.
Endo said that the recalled lots were distributed through wholesale distributors to retail pharmacies around the United States, and the company is providing notices to the retailers and wholesalers that received the impacted lots.
Wholesalers and pharmacies should immediately stop distributing and dispensing the product, it said. Consumers, meanwhile, are urged to discontinue using the recalled product.
“In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician,” the notice said.
A benzodiazepine like Xanax or Valium, clonazepam is used to treat anxiety, seizure, obsessive-compulsive disorder, and panic disorders. The drug, which slows down brain activity and causes sedation or calming effects, is sold under the brand name Klonopin and others.
In many areas of the world and in the United States, the drug is commonly used recreationally.
Other symptoms can include problems with muscle control or coordination, restlessness, irritability, unusual excitement, and nervousness, according to the clinic.