General Neurology

More Clonazepam ODT Recalled Due to Carton Strength Mislabeling

Diana Ernst, RPh
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Publish Date
Recalled clonazepam ODT tablets
Credit: Endo, Inc
At this time, there have been no reports of adverse events related to this recall.
While the blister strips within the cartons reflect the correct strength and lot number, the cartons themselves may not be printed with the correct strength or NDC code.

Endo has expanded the recall of Clonazepam Orally Disintegrating Tablets (ODT) to include additional lots that may potentially be mislabeled.

The Company had initially communicated the issue back in July when it was discovered that 1 lot of product had an incorrect strength printed on the carton label that did not reflect the strength of tablets within the packaging. Since then, Endo has identified additional lots that may be affected by the same issue. While the blister strips within the cartons reflect the correct strength and lot number, the cartons themselves may not be printed with the correct strength or National Drug Code (NDC). 

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. The benzodiazepine is also approved for treating panic disorder.

The products affected by this recall include the following:

  • Clonazepam ODT, USP (C-IV) 2mg; NDC# 49884-310-02; Lot# 550176501, 550176601.
  • Clonazepam ODT, USP (C-IV) 0.125mg; NDC# 49884-306-02; Lot# 550174101.
  • Clonazepam ODT, USP (C-IV) 0.25mg; NDC# 49884-307-02; Lot# 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401.
  • Clonazepam ODT, USP (C-IV) 1mg; NDC# 49884-309-02; Lot# 550145201, 550175901, 550176001, 550176201.

These products were distributed through wholesalers to retail pharmacies nationwide. Retail pharmacies are being instructed to stop dispensing the affected lots. 

Patients inadvertently administered a higher dose of clonazepam may be at increased risk for sedation, dizziness, ataxia, and confusion. Significant respiratory depression may also occur in patients with comorbidities such as pulmonary disease, or those taking concomitant medications that cause respiratory depression.

At this time, there have been no reports of adverse events related to this recall. Additional information can be obtained by calling 855-589-1869 or via email at [email protected].

Adverse reactions or quality issues should be reported to the FDA’s MedWatch program.

This article originally appeared on MPR

References:

Endo expands voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. News release. Endo. November 18, 2024. https://www.prnewswire.com/news-releases/endo-expands-voluntary-recall-of-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-to-potential-product-carton-strength-mislabeling-302309074.html