An anti-anxiety drug is being recalled due to a potentially “life-threatening” mistake.
Endo Co., Ltd. has been issued Voluntary recall for clonazepam For tablets, “the strength indication on the product carton may be incorrect.” in Food and Drug Administration (FDA) recall alert Posted on Nov. 19, the drug company is investigating and expanding on a previously announced voluntary recall of clonazepam. The Pennsylvania-based company First recall on July 16th.
The image above shows an example of a potential mislabel.
“Endo’s ongoing investigation has determined that the clonazepam product lots listed below contained a limited number of incorrect strengths and National Drug Code (NDC) codes printed due to an error by a third-party packager. Cartons have been identified as potentially containing carton,” the FDA alert states. .
“The blister strips and tablets within the product pack reflect the correct strength of the lot,” the warning states.
As of November 18, when Endo Co., Ltd. announced the recall, the company had not received any reports of adverse events related to the recall.
A spokesperson for Endo Co., Ltd. released a statement regarding this recall.
“At Endo, our top priorities are the quality and safety of our products and the well-being of our patients,” Linda Hass said in a statement to USA TODAY. “Our own quality investigation identified potential inaccuracies in third-party vendor labels, leading to the expansion of the recall to a limited number of product lots that were packaged earlier this year. ”
“We have been transparent with our customers and the FDA, and the FDA has reviewed the issue and our response and has resolved the issue,” Hass added.
Here’s what you need to know about the clonazepam recall.
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What is clonazepam?
Clonazepam, known by its brand name Klonopin, is a popular drug used to treat some brain and mental disorders.
Oral medications are commonly used to “have a calming effect on the brain and nerves, reducing anxiety, preventing seizures, and promoting relaxation.” WebMD explains.
What types of Clonazepam are being recalled?
According to Endo Co., Ltd.’s recall, the Clonazepam subject to the voluntary recall is a product packaged in a 60-tablet carton with six tablets in 10 blister strips.
This image shows the lot number.
In a photo provided by the Pennsylvania-based company, a package of Clonazepam Tablets (USP 2 mg lot 550176501) is incorrectly labeled with the carton description and NDC code for Clonazepam Tablets (USP 1 mg 60 counts) This indicates that it may have been affixed.
Clonazepam Recall: See List of Lot Numbers
Can’t see the table? click here To see it.
What are the risk factors for recalled medications?
Endo Co., Ltd. has released the following risk statement regarding the recall.
“Children and adults who inadvertently ingest high doses of clonazepam may be at increased risk for adverse events including significant sedation, confusion, dizziness, decreased reflexes, ataxia, and hypotonia,” the company said. said.
Additionally, the company warns that certain patients may experience side effects.
“This is especially important for patients with concomitant pulmonary disease, those prescribed near-maximal doses, or those who are also taking other medications that can cause further respiratory depression. “There is a good chance that threatening respiratory depression will occur,” the company said.
What should I do if I receive a recalled drug?
The drug company said those in possession of the recalled clonazepam should take the following precautions:
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Distributors and retailers must stop selling recalled products. We strongly recommend that you return the product to the store of purchase or contact Inmar.
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Consumers are advised to discontinue use of this drug.
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If you are a consumer who may have taken an incorrect dose of clonazepam, we recommend contacting your doctor.
For all questions regarding this recall, you can contact Inmar at 877-890-0765, Monday through Friday from 9 a.m. to 5 p.m. Eastern Time, or by email at [email protected] .
This article has been updated to add new information.
Ahjane Forbes is a reporter on USA TODAY’s National Trends team. Ajane covers breaking news, car recalls, crime, food recalls, health, lottery, and public policy topics. Please email her at [email protected]. follow her Instagram, thread and X (Twitter) @forbesfinest.
This article originally appeared on USA TODAY. Anxiety drug clonazepam recalled for mislabeling: See lot number
