A popular Attention Deficit Hyperactivity Disorder (ADHD) medication has been recalled after a different medication was found inside the packaging.
Azurity Pharmaceuticals has recalled their 30-milligram dextroamphetamine sulfate tablets sold under the brand name Zenzedi.
The move was made after a pharmacist in Nebraska opened a bottle to find tablets of Carbinoxamine Maleate, an antihistamine drug, mixed in with the ADHD medication, the Food and Drug Administration warned.
The recalled products — a part of lot number F230169A — expire in June 2025 and were recalled on Jan. 4.
The two medications have opposite effects.
Dextroamphetamine sulfate is a stimulant whereas carbinoxamine maleate, an antihistamine that is used to treat allergies, has a sedative effect.
“Patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA explained.
Those who unknowingly take carbinoxamine “could 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.”
People who have been diagnosed with ADHD or narcolepsy have a “reasonable probability” that accidents or injuries that occur from accidentally taking carbinoxamine “could lead to ongoing disability or death” when partaking in activities that require focus and alertness such as driving or operating heavy machinery.
Zenzedi 30 milligram tablets will be light yellow hexagonal tablets with “30” on one side and “MIA” on the other side. The ADHD medication should be distributed in a white bottle with black writing and “30 mg” highlighted yellow.
Meanwhile, carbinoxamine maleate 4-milligram tablets are white round tablets with imprints of “GL” on one side and “211” on the other.
Patients with recalled products are advised to stop using them and return to the place of purchase.
This news is particularly distressing as the country continues to experience a shortage of common ADHD medications, such as Adderall.