Anxiety drug recalled nationally due to ‘possibly life-threatening’ label error

DETROIT — Anti-anxiety drug clonazepam was recalled due to incorrect dose information.

Endo, the maker of orally disintegrating clonazepam tablets, said the cartons were labeled with the wrong dosage of the drug, which could lead to patients taking the wrong dosages.

The company stated that some packaging shows The strength of the product is incorrectly stated due to a third party packer error. The blister strips inside the cartons reflect the correct strength.

Those taking higher doses of clonazepam experienced sedation, confusion, dizziness, decreased reflexes, ataxia, and hypotension. The company said it is possible that other people may experience life-threatening respiratory depression, especially if they have underlying lung disease and in patients prescribed doses near the maximum.

Package identification:

The drug is packaged in cardboard boxes of 60 tablets, packed in 10 blisters of 6 tablets each. The name, strength, batch number, expiration date and NDC number are printed on the carton and each blister strip pocket. The packaging identifies the legacy company as Par Pharmaceutical, which previously sold clonazepam before the product was acquired by Endo.

Consumers who have unused cartons of Clonazepam Orally Disintegrating Tablets, USP with the lot numbers listed above are advised to stop using the product.

Adverse reactions or quality problems encountered with this batch of product may be reported to US Food and Drug Administration MedWatch Adverse Event Reporting Program..