ADHD Meds Are Being Recalled After Dangerous Label Mix-Up, FDA Warns
Patients who take the wrong medication could face serious adverse events.
Once you're in the habit, taking a prescription every day becomes a pretty mindless task. With that in mind, you probably don't think to inspect the pills themselves—especially since some meds come in different shapes and colors depending on whether you get brand-name or generic varieties in a given month. But mistakes do happen, and now, attention-deficit/hyperactivity disorder (ADHD) and narcolepsy medication Zenzedi has been recalled after a mislabeling mistake during manufacturing.
According to a Jan. 24 alert from the U.S. Food and Drug Administration (FDA), Massachusetts-based Azurity Pharmaceuticals, Inc. is recalling one lot of dextroamphetamine sulfate tablets, USP in the 30-milligram dose. The medication, which is a Schedule II controlled substance and known by the brand name Zenzedi, is prescribed to treat ADHD as well as narcolepsy, according to the FDA.
The meds were recalled after a pharmacist in Nebraska opened a bottle of Zenzedi 30-mg tablets and instead found carbinoxamine maleate, which is an antihistamine drug, per the FDA. The manufacturer then opened a product complaint and started an investigation. Recalled products were distributed nationwide through pharmacies.
The FDA warns that those who unknowingly take carbinoxamine may experience adverse events "which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder."
Those who are prescribed Zenzedi and take carbinoxamine instead will also have undertreatment of their symptoms, which could lead to "functional impairment and an increased risk of accidents or injury," the agency says.
"For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery)," the FDA alert reads.
To be safe, you'll want to double-check the pills you have at home if you're prescribed this medication. Zenzedi 30-mg tablets are light yellow, hexagonal tablets that have "30" on one side and "MIA" on the other. They are distributed in white bottles and have "30 mg" highlighted in yellow. You can distinguish these from the Carbinoxamine Maleate Tablets USP, 4 mg tablets, which are white round tablets with "GL" on one side and "211" on the other side.
The recalled lot has a National Drug Code (NDC) number of 24338-856, a lot number of F230169A, and an expiration date of June 2025. Azurity alerted wholesale distributors of the recall back on Jan. 4, but if you have affected products at home, stop using them and return them to your place of purchase, the FDA says.
As of the Jan. 24 FDA alert, Azurity hadn't received any reports of serious adverse events related to the recall. But if you do experience any problems, you should contact your doctor or healthcare provider and report the adverse event to Azurity via email ([email protected]). The FDA also asks that you report adverse reactions or quality problems to its MedWatch Adverse Event Reporting program online, or via mail or fax.