Endo USA, Inc., affiliated to generics and specialty branded pharmaceutical company Endo, Inc., is recalling one lot of Par Pharmaceutical, Inc.'s Clonazepam Orally Disintegrating Tablets, according to the U.S. Food and Drug Administration. The recalls drugs were mislabeled with the incorrect strength on the carton.
Clonazepam Orally Disintegrating Tablets are indicated alone for as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.
The recall impacts Clonazepam Orally Disintegrating Tablets, USP 0.25 mg as well as USP 0.125 mg, both packaged in 60-count carton, with lot 550147301 and expiration date August 2026.
The product lot was distributed through wholesale distributors to retail pharmacies nationwide.
According to the agency, 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. The blister strips inside the product pack reflect the correct strength of 0.25 mg.
Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam may experience adverse effects of significant sedation, dizziness, ataxia, and confusion. Some patients may experience significant, possibly life-threatening, respiratory depression especially for those with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
However, Endo has not received any reports of adverse events associated with the drug recall so far.
Consumers with any unused prescribed 60 tablet cartons of recalled Clonazepam Orally Disintegrating tablets, USP 0.25mg which may also appear as Clonazepam Orally Disintegrating tablets USP 0.125mg are asked to discontinue use of the product.
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
Retailers can return all existing inventory through Inmar, Inc.
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