Clonazepam, which is sometimes marketed as Klonopin, is a benzodiazepine that is approved by the FDA to treat anxiety, epilepsy, and panic disorders. Off-label, the drug can be prescribed for restless leg syndrome, insomnia, and acute mania. The single product lot of Clonazepam Orally Disintegrating tablets was recalled because of a “mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.
125 mg and not 0.25 mg due to an error at a third-party packager,” Endo USA said in the FDA notice. The blister strips inside the packaging show the correct strength of 0.
25 mg, according to the notice. Adults and children who are “inadvertently prescribed a two-fold overdose” could suffer health problems such as confusion, “significant sedation,” dizziness, and ataxia, or muscle weakness. The company warned that the mislabeling could increase the possibility of “significant” and “possibly life-threatening” respiratory issues for individuals with concomitant pulmonary disease as well as people who are taking other medication that could cause additional respiratory depression and for people who are taking near the maximum dose of clonazepam.
The firm said it has not received any reports of any adverse health events linked to the now-recalled product. Consumers who have any unused, prescribed 60-tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg, that may also appear as Clonazepam Orally Disintegrating tablets, USP 0.
125mg, should not use the product, the recall notice said. The packages feature the product’s name, the lot number, the expiration date, the strength, and the National Drug Code number. A review of the labels included in the announcement shows that National Drug Codes 49884-307-02 and 49884-306-02 are displayed.
The Epoch Times contacted Endo USA for comment on Monday. “In the event that a patient inadvertently took a 0.25 mg dose rather than the intended 0.
125 mg dose, they are advised to consult a physician,” the company said. The impacted lot was distributed through wholesale distributors to retail pharmacies across the United States. A written notification from Endo will be provided to the wholesale companies and retailers that have received the lot, it said, adding that it will arrange for the return of the existing product.
“Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact (distributor) Inmar,” it said. “Clonazepam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to,” the agency also warns, adding that the medication can also cause a physical dependence.
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