Once you get used to it, taking your prescription every day can be quite a daunting task. With that in mind, you probably won't want to test the pills themselves. Especially since some drugs come in different shapes and colors depending on whether you buy the brand name or generic version in a given month. But mistakes happen, and Zenzedi, a drug used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently being recalled due to a labeling error during manufacturing.
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according to Warning for January 24th The U.S. Food and Drug Administration (FDA) is recalling one lot of 30-milligram dose dextroamphetamine sulfate tablets (USP) from Massachusetts-based Azurity Pharmaceuticals. The drug is a Schedule II controlled substance, known by the brand name Zenzedi, and is prescribed to treat ADHD as well as narcolepsy, according to the FDA.
The drug was recalled after a pharmacist in Nebraska opened a bottle of Zenzedi 30mg tablets and found carbinoxamine maleate, an antihistamine, instead, the FDA said. The manufacturer then filed a complaint about the product and began an investigation. The recalled products were distributed nationwide through pharmacies.
The FDA states that people who unknowingly take carbinoxamine experience adverse events “including, but not limited to, drowsiness, drowsiness, central nervous system (CNS) depression, increased intraocular pressure, enlarged prostate, urinary tract obstruction, and thyroid disorders.” It warns that there is a possibility that
People prescribed Zenzedi who take carbinoxamine instead may also have their symptoms undertreated, leading to “impaired functioning and an increased risk of accidents and injuries,” the agency said.
“In patients with attention-deficit/hyperactivity disorder (ADHD) and narcolepsy (sleep disorders), accidents and injuries caused by the sedative effects of carbinoxamine, especially in individuals, can lead to continued disability or death in severe cases. There is a good chance that the person using it (who is not aware that they are not receiving Zenzedi®) will be able to engage in activities that require significant concentration and alertness (e.g. driving a car, operating heavy machinery). ),” the FDA warning says.
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If you have been prescribed this medication, please double check the medications you have at home to be safe. Zenzedi 30 mg tablets are pale yellow hexagonal tablets with “30” written on one side and “MIA” written on the other side. These are distributed in white bottles with “30 mg” highlighted in yellow. These can be distinguished from the 4 mg tablets of Carbinoxamine Maleate Tablets USP, which are white round tablets with “GL” on one side and “211” on the other.
The National Drug Code (NDC) number for the recalled lot is 24338-856, the lot number is F230169A, and the expiration date is June 2025. Azurity warned wholesale distributors about the recall on January 4th, but if you have an affected product, please stop using it at home and return it to the place of purchase, the FDA says. .
As of the FDA warning on January 24, Azurity had not received any reports of serious adverse events related to the recall. However, if you experience a problem, you must contact your doctor or health care provider and report the adverse event to Azurity via email ([email protected]). The FDA also requires you to report side effects or quality issues to its MedWatch Adverse Event Reporting Program. onlineor via email or fax.
