The drug clonazepam, used to treat anxiety, seizures and muscle spasms, is being recalled over a potentially fatal mislabeling mistake.
Endo Inc., based in Pennsylvania, has announced a voluntary recall of 16 lots of Clonazepam Orally Disintegrating Tablets after it discovered that a number of cartons may have been printed with the incorrect strength and National Drug Code (NDC) on them.
Children and adults prescribed these drugs could mistakenly be taking the wrong dose as a result, putting them at risk of unpleasant and dangerous side effects.
These side effects could include significant sedation, confusion, dizziness, diminished reflexes, ataxia—where balance, coordination and speech become less controlled—and hypotonia, also known as low muscle tone or floppy muscle syndrome.
Endo stated on their website: “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.”
Respiratory depression is a condition where breathing becomes slow, shallow or ineffective, and can be fatal.
Clonazepam is prescribed to treat seizure disorders, such as epilepsy, panic disorder—a form of anxiety where an individual suffers frequently from panic attacks—and other complaints, such as restless leg syndrome or muscle spasms.
It works by increasing the levels of gamma-aminobutyric acid (GABA), a calming chemical, in the brain, which can relieve anxiety, stop seizures and relax tense muscles.
As of this Monday, Endo had not received any reports of adverse events in relation to this recall.
Tablets Recalled Due to Potential Mislabeling
The lots of clonazepam affected by Endo’s voluntary recall of potentially mislabeled tablets. These products may contain a different strength of drug to what is written on the packet.
A table showing the clonazepam tablets recalled by Endo due to potential mislabeling, including a description of the four products affected, a list of their National Drug Code numbers, a list of lots affected and some images of the 1mg product.
Table with 4 columns and 4 rows.
Product Description NDC Number Lot Images
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 Clonazepam Orally Disintegrating Tablets 1mg Clonazepam Orally Disintegrating Tablets Back
