Popular anxiety drug clonazepam recalled for labeling error
Additional packages of clonazepam, a prescription medication used to treat seizures and anxiety, mislabeled with the incorrect strength have been added to a voluntary recall, according to the U.S. Food and Drug Administration.
Endo, Inc., the manufacturer of clonazepam, expanded the recall, first announced in July, to 16 lots of the medication, according to a recall notice shared by the FDA on Nov. 19.
The recalled product, clonazepam Orally Disintegrating Tablets, comes in cartons, "containing 60 tablets packed into 10 blister strips each containing 6 tablets," according to Endo.
The affected cartons are printed with the incorrect strength and National Drug Code, while the blister strips and tablets inside reflect the correct strength, according to the company, which blamed the error on a "third-party packager."
Both Endo's and the FDA's recall notices include the list of affected lot numbers, which are also visible on the product packaging.
The packaging of recalled products says "Distributed by: Par Pharmaceutical," which marketed clonazepam before it was acquired by Endo, according to the company.
Consumers with a recalled package are advised to "discontinue use" of the product.
If a consumer is concerned they may have taken an incorrect dose of clonazepam, they are advised by Endo to "consult a physician."
According to Endo, no adverse events have been reported so far in relation to the recalled products.
The company warns that children and adults who take an incorrect dose of clonazepam are at risk for an adverse reaction.
"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," Endo said in the recall 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."
The recalled products were distributed nationwide according to Endo, which said it is working with another company, Inmar, Inc., to have all the existing inventory of affected products returned.
Consumers may contact Inmar with questions by email at rxrecalls@inmar.com and by telephone at 855-589-1869, Monday through Friday, 9 a.m. to 5 p.m. ET.
Clonazepam, in a class of medications called benzodiazepines, works by, "decreasing abnormal electrical activity in the brain," according to the U.S. National Library of Medicine.
The drug is used to help control certain types of seizures and to help relieve panic attacks. It is typically taken one to three times a day with or without food, according to the NLM.
