FX.co ★ Endo USA Recalls Clonazepam Orally Disintegrating Tablets

Endo USA, Inc., a subsidiary of the generics and specialty branded pharmaceutical company Endo, Inc., is issuing a recall for one lot of Par Pharmaceutical, Inc.'s Clonazepam Orally Disintegrating Tablets, as announced by the U.S. Food and Drug Administration (FDA). The affected drugs were mislabeled with incorrect strength information on the carton.

Clonazepam Orally Disintegrating Tablets are indicated for use alone or as an adjunct in the treatment of Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.

This recall affects Clonazepam Orally Disintegrating Tablets, USP 0.25 mg, and USP 0.125 mg, both packaged in 60-count cartons, with lot number 550147301 and an expiration date of August 2026.

The product lot was distributed nationwide through wholesale distributors to retail pharmacies.

The FDA indicated that an error at a third-party packager resulted in some cartons being incorrectly labeled to show the product strength as 0.125 mg instead of 0.25 mg. However, the blister strips inside the packaging correctly display the strength of 0.25 mg.

Children and adults inadvertently prescribed a two-fold overdose of clonazepam may experience significant adverse effects, such as sedation, dizziness, ataxia, and confusion. Patients may also face the risk of life-threatening respiratory depression, particularly those with concomitant pulmonary disease, those prescribed near-maximal dosing, and those taking additional medications that cause respiratory depression.

To date, Endo has not received any reports of adverse events associated with this recall.

Consumers with unused prescribed 60-tablet cartons of the recalled Clonazepam Orally Disintegrating Tablets, USP 0.25 mg, which may be mislabeled as Clonazepam Orally Disintegrating Tablets, USP 0.125 mg, should discontinue use of the product immediately.

Patients who inadvertently took a 0.25 mg dose instead of the intended 0.125 mg dose are advised to consult their physician.

Retailers are instructed to return all existing inventory through Inmar, Inc.