Safety Report: Clonazepam Orally Disintegrating Tablets - recalled due to Mislabeling, USA

United States

Endo USA, Inc. is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets to the consumer level. The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons. The product lot was distributed through wholesale distributors to retail pharmacies nationwide.

Risk Statement: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation. There is a reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have been prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.

This recall impacts the following product lot:
- Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026
- Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026
The product is packaged in cartons of 60 tablets. Impacted units will display the NDC code 49884-306-02.

Distributors and retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase. Patients inadvertently took a 0.25 mg dose rather than the intended 0.125 mg dose, they are advised to consult a physician.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Endo USA, Inc
Brand name: Par Pharmaceutical
Product recalled: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets
Reason for the recall: Mislabeled with the incorrect strength on the carton
FDA Recall date: July 17, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp