FDA MedWatch – One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 by Endo USA

TOPIC: One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 by Endo USA: Recall – Due to Mislabeling: Incorrect Strength on Product Carton

AUDIENCE: Patient, Health Professional, Pharmacy, Neurology

ISSUE: Endo USA is recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.

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, dizziness, ataxia, and confusion. 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.

To date, Endo has not received any reports of adverse events associated with this product lot recall.

The product lot was distributed through wholesale distributors to retail pharmacies nationwide. 

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Clonazepam Orally Disintegrating Tablets are indicated alone for as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder. 

RECOMMENDATIONS: 

• Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line.

• Consumers in possession of any unused prescribed 60 tablet cartons of Clonazepam Orally Disintegrating Tablets, USP 0.25 mg which may also appear as Clonazepam Orally Disintegrating Tablets USP 0.125 mg bearing the lot number 550147301 have been advised to discontinue use of the product.

• 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.

• Consumers with questions regarding this recall can contact Inmar by telephone at 877-890- 0765 or by email at rxrecalls@inmar.com.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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