Maia PandeyAhjané Forbes
An anxiety drug is being voluntarily recalled over a mislabeling error that could be “possibly life-threatening," according to the U.S. Food and Drug Administration.
Some packages of clonazepam were labeled with the incorrect dosage strength and National Drug Code (NDC), which is the FDA's identifier for drugs, according to Endo, Inc., the drug's manufacturer. Endo originally issued a recall over the error in July but expanded it on Nov. 18.
The issue was caused by a third-party packager, the company said.
"Our own quality investigation identified a potential label inaccuracy at a third-party vendor, leading to this expanded recall of to a limited number of product lots that were packaged earlier this year," Linda Huss, an Endo, Inc. spokesperson, told USA TODAY.
Clonazepam, also known by its brand name Klonopin, is a drug used to anxiety, seizures and panic disorder. Though entirely legal when prescribed by a medical professional, it is illegal federally, including in Wisconsin, to unlawfully possess Klonopin.
Here is what to know about the Clonazepam recall.
What types of Clonazepam are being recalled?
According to Endo, Inc.’s recall, the Clonazepam being recalled is in cartons containing 60 tablets that are packed into 10 blister strips, containing six tablets each.
To know if your pills are part of the recall, check if the package's lot number or NDC match up with any on the list provided by the FDA.
What are the risk factors of the recalled drug?
Children and adults who consume the higher dose could be at increased risk of "adverse events," including significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia, Endo, Inc. said.
The company also warned of additional side effects for patients with specific risk factors.
“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 recall notice said.
Has anyone gotten sick over the mislabeling error?
As of Nov. 18, when Endo, Inc. issued its recall, the company said it has not received any reports of adverse events related to the recall.
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:
- Distributors and retailers should stop dispensing the recalled product. It is highly recommended that the product be returned to the place of purchase or to contact Inmar.
- Consumers are encouraged to discontinue using the drug.
- If you are a consumer that may have taken an incorrect dose of Clonazepam it is advised to contact your doctor.
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