Endo Recalls Clonazepam Because of Mislabeling

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FDA announced on July 17, 2024 that Endo Inc.’s subsidiary, Endo USA, is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets (also seen as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count) because an incorrect strength appears on the cartons of some packs. The product strength is listed as 0.125 mg and not 0.25 mg. The error was made by a third-party packager. The inside blister strips have the correct strength of 0.25 mg noted.

The recalled lot, which was distributed through wholesale distributors to retail pharmacies nationwide,includes Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026, and Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026; National Drug Code (NDC) number 49884-306-02. The product is packaged in cartons of 60 tablets.

Clonazepam Orally Disintegrating Tablets are used as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, as well as panic disorders. Significant sedation, dizziness, ataxia, and confusion may result in children and adults who take a larger dose than prescribed. There is potential for life-threatening respiratory depression, especially in patients with concomitant pulmonary disease, patients prescribed doses near the maximum dosing allowed, and patients taking other medications. “In the event that a patient inadvertently took a 0.25 mg dose rather than the intended 0.125 mg dose, they are advised to consult a physician,” the company stated in the press release (1).

The company stated it has not yet received any reports of adverse events related to the recall. Adverse events may be reported to FDA through its MedWatch program.

Written notification is being sent to wholesale distributors and retailers so that the impacted lot can be returned. “Consumers in possession of any unused prescribed 60 tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg, which may also appear as Clonazepam Orally Disintegrating tablets USP 0.125mg bearing the lot number 550147301 have been advised to discontinue use of the product,” the company stated in the release.

Recalls can result in quality issues that impact drug supplies. In February 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health (2). Postmarketing surveillance and risk evaluations are performed by FDA on products to identify new adverse events that were not present in the approval process. New information is investigated by the agency and may require changes in prescribing information or modification of a Risk Evaluation and Mitigation Strategy. CDER’s pharmacovigilance efforts in 2023 included reviews of 15 newly identified safety signals (NISS). One of these NISS was related to naloxone hydrochloride product administration. There were attempts to administer a syringe that had no needle. In response, FDA required changes to carton labeling to include a warning that said, “Needle not included.”

References

1. FDA. Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton. Press Release, July 17, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp
2. Haigney, S. FDA’s Drug Safety Priorities for 2023. PharmTech.com. Feb. 21, 2024. https://www.pharmtech.com/view/fda-s-drug-safety-priorities-for-2023