According to the FDA, Malvern, Pennsylvania-based Endo, Inc announced that a single lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets has been recalled by one of its subsidiaries, Endo USA, Inc., because the product carton may feature the incorrect strength.
Officials say that while products under lot 550147301 and expiration date August 2026 may have blister strips inside the product pack that show the correct strength (0.25 mg), the product cartons appears to be labeled for the 60-count packs Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets.
Indicated to be taken alone or along with treatment of Lennoz-Gastaut syndrome (petit mal variant), or akinetic and myoclonic seizures, Clonazepam Orally Disintegrating Tablets are also used to treat panic disorders.
Both children and adults who take a “two-fold overdose” of the product by mistake may experience the following adverse effects:
- significant sedation
- dizziness
- ataxis
- confusion
In patients with concomitant pulmonary disease, in patients who take close to a maximum dosage, or in patients who are also being administered other medications that may lead to further respiratory depression, officials have identified a “reasonable probability” for major respiratory depression that could turn life-threatening. Despite these risks, Endo has not been made aware of any adverse health outcomes connected to the recall to date.
As shown in product photos attached to the FDA announcement, labels on the cartons feature the name of the product, its dosage strength, lot number, the expiration date, as well as its National Drug Code (NDC) 49884-307-02. Consumers should note that affected products will bear the NDC code 49884-306-02.
Announced by Endo USA, Inc. on July 16, 2024, the voluntary recall covers products that were distributed via wholesale distributing partners to retail pharmacies across the U.S. Endo has since alerted the receiving wholesalers and retailers by print communication that product lot 550147301 is impacted, and a return program for all existing inventory has been established through Inmar, Inc. All distributors and retailers with unused cartons of 60-tablet Clonazepam Orally Disintegrating tablets, USP 0.25mg (which may be packaged as Clonazepam Orally Disintegrating tablets USP 0.125mg) under the recalled lot should cease all distribution, return the items to the point of purchase, or reach out to Inmar by calling 877-890-0765. Inmar representatives can be reached Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time, or via email at rxrecalls@inmar.com.
Anyone who may have inadvertently taken a 0.25 mg dose when they meant to take a 0.125 mg dose is urged to contact their medical provider.
The FDA asks that consumers report any adverse reactions or quality issues to the agency’s MedWatch Adverse Event Reporting program as it continues to monitor the recall.
If you or a loved one have suffered an overdose and/or an adverse health outcome that can be traced to a medical drug mislabeling, your family deserves maximum compensation. Our experienced attorneys at TruLaw are here to help you navigate the legal process and demand accountability from negligent parties. To learn about how we can support you in the next steps, reach out online or take our free Instant Case Evaluation ℠.