An anxiety drug is being voluntarily recalled over an error that could be "life-threatening".
Endo, Inc. issued a voluntary recall for Clonazepam tablets "due to potential product carton strength mislabeling." In the Food and Drug Administration's (FDA) recall alert posted on Nov. 19, the pharmaceutical company is investigating and expanding its previously announced voluntary recall of Clonazepam. The Pennsylvania-based company issued the first recall on July 16.
"Endo's ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager," the FDA's alert said.
"The blister strips and tablets inside the product pack reflect the correct strength for the lot," the alert said.
As of Nov. 18, when Endo, Inc. issued its recall, the company did not receive any reports of adverse events related to the recall.
USA TODAY reached out to Endo, Inc. for comment.
Here is what you need to know about the Clonazepam recall.
What is Clonazepam?
Clonazepam, known by its brand name Klonopin, is a popular drug that is used to treat some brain and mental disorders.
The oral medication is commonly used to provide "a calming effect on the brain and nerves, which helps to reduce anxiety, prevent seizures, and promote relaxation", WebMD explains.
What types of Clonazepam are being recalled?
According to Endo, Inc's recall, the Clonazepam that is being voluntarily recalled is the product packaged in cartons containing 60 tablets that are packed into 10 blister strips and contain six tablets.
In photos provided by Pennsylvania-based company it shows the potential mislabeling of a package of the Clonazepam tablets, USP 2 mg lot 550176501 with a carton description and NDC code of Clonazepam tablets, USP 1 mg 60-count.
Endo, Inc. issued the following risk statement in the recall:
"Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia," the company said.
In addition, the company warns of the possible side effects for specific patients.
"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," the company said.
What should you do if you have the recalled drug?
The pharmaceutical company said the following precautionary measures should be taken if you have any of the recalled Clonazepam:
For all questions regarding this recall, you can contact Inmar at 877-890-0765 on Monday through Friday from 9 a.m. to 5 p.m. ET or by email at [email protected].