A pharmaceutical company expanded its prior recall of anti-anxiety drug clonazepam tablets due to a potential “mislabeling” about the product’s strength on its carton that could be “life-threatening,” according to an announcement published by the U.S. Food and Drug Administration (FDA).
In the notice updated Nov. 19, Endo Inc. said that the impacted products, already under recall, are Clonazepam Orally Disintegrating Tablets, USP.
An ongoing investigation initiated by the firm shows there is a chance more impacted product lots “contain a limited number of cartons printed with the incorrect strength” and incorrect National Drug Code because of “an error by a third-party packager,” it said.
The clonazepam was packaged by Par Pharmaceutical before the drug was acquired by Endo, according to the notice.
“Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” said the notice.
“There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.”
But so far, the company said it has not received any reports of adverse reactions from the recalled drugs.