A popular anxiety drug taken by nearly two million Americans is being recalled nationwide due to a “life-threatening” packaging error.
Sixteen lots of clonazepam sold by Par Pharmaceutical had the wrong dosage strength printed on their labels.
The recall, issued by manufacturer Endo Inc., affects orally disintegrating tablets of 0.125 milligrams (mg), 0.25 mg, 1 mg and 2 mg.
The incorrect dosage strength is stated on the box in which the medications are sold, while the correct dose is printed on the blister strips and tablets inside.
Endo has warned patients to immediately stop using the recalled products, saying there was a “reasonable chance” they could experience “life-threatening respiratory depression” when breathing becomes dangerously slow.
Patients taking the maximum dose of clonazepam (2 mg), those with lung disease, or taking other drugs that can cause respiratory depression are at greatest risk.
Pennsylvania-based Endo has blamed an unnamed “third-party packager” for the error.
There have been no reports of serious side effects due to the error, the company said.
The above image shows the packaging of the recalled Clonazepam medications
Patients who have the drug are urged to throw it away immediately and contact their pharmacy for a replacement.
Those who have taken the recalled pills should contact their doctor immediately.
A total of 16 lots of the drug have been recalled, with each pack containing 60 tablets packaged in 10 blister strips containing six pills each.
It is not clear how many packages were in one batch.
Patients are urged to check the lot number of their medicine, which is printed on the blister packs, to see if their dose is being recalled.
A list of the lottery numbers can be found here.
In its voluntary recall, also published by the FDA, the manufacturer said: ‘Children and adults who inadvertently consume a higher dose of Clonazepam may be at increased risk for the side effects of significant sedation, confusion, dizziness, decreased reflexes, ataxia, and hypotonia. .’
Above is the packaging of the recalled Clonazepam medications. They had the brand name Par Pharmaceuticals
Ataxia is loss of muscle coordination, leading to clumsy movements, and hypotonia is a decreased resistance of the muscles to movement, making them appear limp.
The manufacturer added: ‘There is a reasonable risk of significant, potentially life-threatening respiratory problems.
‘[This is] especially for patients with concurrent lung disease, patients prescribed dosages close to maximum dosage, and patients who are also taking other medications that may cause additional respiratory distress.”
Clonazepam is often prescribed to treat seizures, epilepsy, and panic disorder, a form of anxiety.
It works by increasing the level of gamma-aminobutyric acid (GABA) in the brain, which helps calm the nervous system and relax muscles.
More than 23 million prescriptions for the drug are written each year in the US.