DETROIT – Anxiety medication clonazepam has been recalled due to incorrect dose information.
Endo, the manufacturer of Clonazepam Orally Disintegrating Tablets, said that the medication’s strength is mislabeled on the cartons, which could lead to patients taking incorrect dosages.
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The company said some packs show the product strength incorrectly due to an error at a third-party packager. The blister strips inside the cartons reflect the correct strength.
Those who consume a higher dose of clonazepam could see sedation, confusion, dizziness, diminished reflexes, ataxia and hypotonia. The company said there it’s possible that others may see life-threatening respiratory depression -- especially if they have concomitant pulmonary disease and patients who have been prescribed near maximal dosing.
Package Identification:
The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo.
| Potential Product Description / NDC Number | Lot Numbers |
|---|---|
| Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 | 550176501 550176601 |
| Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 | 550174101 |
| Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 | 550142801 550142901 550143001 550143101 550143201 550143301 550143401 550147201 550147401 |
| Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 | 550145201 550175901 550176001 550176201 |
Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product.
Adverse reactions or quality problems experienced with the use of this product lot may be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program.
