Clonazepam Recall Grows Over Dangerous Labelling Error

Endo USA, Inc, has expanded its previously announced recall of clonazepam orally disintegrating tablets due to a packaging error that could be life-threatening.

An ongoing investigation by the company has identified the possibility that certain clonazepam product lots contain cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. 

“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,” the company said in the recall announcement posted this week on the US Food and Drug Administration (FDA) website. 

“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 company warned. 

Clonazepam (USP, C-IV) is used to treat seizures, panic disorder, and anxiety. 

The company recalled two lots of clonazepam due to mislabeled cartons back in July. 

The recall now includes 16 lots of the drug. They are:

The recalled clonazepam products are packaged in cartons containing 60 tablets packed into 10 blister strips each containing six tablets.

The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The blister strips and tablets inside the product pack reflect the correct strength for the lot. The mistake appears on the product cartons. 

Action Required 

The recalled product lots were distributed through wholesale distributors to retail pharmacies nationwide. Endo is alerting wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc.

Consumers in possession of any recalled product should immediately stop using it. Any patient who inadvertently took an incorrect dose rather than the intended dose should contact their physician. 

Questions regarding this recall can be directed to Inmar by telephone at 855-589-1869 (Monday-Friday, 9 AM-5 PM ET) or by email at rxrecalls@inmar.com.

Adverse reactions or quality problems related to this recall may be reported to the FDA MedWatch Adverse Event Reporting program.