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Tablets of the drug clonazepam, the generic name for Klonopin, which is used to treat epilepsy, panic disorder and muscle spasms, have been recalled for incorrect labeling that could inadvertently cause people to take a potentially fatal higher dose. The Pennsylvania-based company Endo, Inc., issued a for Clonazepam Orally Disintegrating Tablets because "a limited number of cartons" were printed with the incorrect strength and National Drug Code.
Following an investigation, the company determined the error was made by a third-party packager. The blister strips and tablets inside the pack have the correct strength listed on them, according to the press release. As of Nov.
18, when the release was published, the company had not received any reports of adverse events associated with the mislabeled drugs. The company said in its recall notice that there is a "reasonable probability" of children and adults who inadvertently take a higher dose going into potentially life-threatening respiratory depression. The condition causes people to breathe too slowly or shallowly, which may lead to low oxygen in the blood and can be potentially fatal, according to the .
The threat of respiratory depression from the mislabeled cartons is particularly acute for patients with pulmonary disease, those who have been prescribed a near maximum dose and patients taking other medications that could cause additional respiratory depression, the company stated. Other potential side effects of accidentally taking a higher dose of the drug include significant sedation, confusion, dizziness, diminished reflexes, loss of muscle coordination and muscle weakness. In addition to treating anxiety and seizures, clonazepam also has off-label uses for restless leg syndrome, acute mania, insomnia and the neurological condition tardive dyskinesia, which causes involuntary movements, according to the .
The affected drugs, which were distributed to pharmacies nationwide, are packed in cartons that hold 60 tablets packed into 10 blister strips that each contain six tablets. The carton and blister strips are printed with the name, strength, lot number, expiration date and NDC number. The company name Par Pharmaceutical, which previously marketed clonazepam before it was bought by Endo, is also on the package.
The includes the list of recalled products including their lot numbers. Anyone possessing unused tablets affected by the recall is advised to stop using them, and anyone who inadvertently took the wrong dose is advised to consult a doctor. Endo has also arranged for the return of all the existing inventory and notified wholesalers and retailers to stop distributing and dispensing the drug.
Consumers with questions can contact Inmar, Inc. at 855-589- 1869, Monday through Friday from 9 a.m.
to 5 p.m. ET, or by email at rxrecalls@inmar.
com. Scott Stump is a trending reporter and the writer of the daily newsletter This is TODAY (which you should ) that brings the day's news, health tips, parenting stories, recipes and a daily delight right to your inbox. He has been a regular contributor for TODAY.
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