ROCHESTER, MI – As many as 16 lots of Clonazepam Orally Disintegrating Tablets, USP (C-IV) have been added to a voluntary recall by Endo USA, Inc., because the product cartons may be labeled with the incorrect strength, according to the FDA.
Indicated to be taken alone or “as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures,” Clonazepam Orally Disintegrating Tablets are also used to treat panic disorder.
The recall was announced by Endo, Inc., on November 18, 2024, and by the FDA on the following day, November 19, 2024. Company officials said an ongoing internal investigation found that among the sixteen Clonazepam product lots is a limited number of cartons bearing the incorrect product strength and National Drug Code (NDC). The company said the error originated with a third party partner that packaged the units. Despite the carton mislabeling, officials confirmed that the product pack’s blister strips and tablets bear the correct strength.
Consumers are asked to be aware of the following additional lots now covered by the original recall:
- Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02
- Lot #s: 550176501, 550176601
- Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02
- Lot #: 550174101
- Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02
- Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401
- Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02
- 550145201, 550175901, 550176001, 550176201
- 550145201, 550175901, 550176001, 550176201
As can be referenced in the product photo attached to the FDA announcement, each carton contains 10 blister packs with 6 tablets apiece, totally 60 tablets. The product name, strength, lot number, NDC number, and expiration date are printed on both the carton and on each blister strip pocket. The legacy company Par Pharmaceutical is also listed on the packaging.
Endo has since notified impacted wholesale and retail partners of the recall, and a return program for all existing inventory has been arranged by third-party company Ingmar, Inc.
All distributors and retailers are asked to cease distribution of any remaining Clonazepem Orally Disintegrating Tablets, USP with the above lot numbers, and any consumer who may have been prescribed tablet cartons of the product is asked to discontinue use.
Anyone who may have taken a dose that exceeds their intended dose should contact their medical provider.
Consumers should note that children and adults who inadvertently consume a higher dose of the product puts themselves at risk for a number of symptoms and other adverse conditions that include: “significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia.” Some individuals (particularly those with concomitant pulmonary disease, those whose prescriptions are near the maximum dose, and those on other medications) may also be at heightened risk for a “significant, possibly life-threatening, respiratory depression.”
Have you suffered an overdose or other adverse health outcome that can be traced to a medical drug mislabeling? Our compassionate team at Oliver Law Office is prepared to learn about your case and build a case for the compensation you deserve. Our attorneys come with a range of knowledge and experience in mass tort litigation and are personally invested in helping you move forward with the resources you need. Call our office today at 614-220-9100 or visit us online to book a free case review.
