STATEN ISLAND, N.Y. — Medication prescribed for patients with Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy (sleep disorder) has been recalled, as the bottles may have the wrong pills in them, according to a notice posted by the U.S. Food and Drug Administration (FDA).
Azurity Pharmaceuticals Inc. is voluntarily recalling one lot (F230169A) of Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level due to mislabeling. The product is being recalled after a pharmacist in Nebraska opened a bottle of Zenzedi CII 30 mg tablets and found tablets of an antihistamine drug, carbinoxamine maleate.
The products under the recall were shipped to wholesalers from Aug. 23, 2023, to Nov. 29, 2023. They have an expiration date of June 2025.
Zenzedi 30 mg tablets can be identified by a light yellow hexagonal tablet debossed with “30″ on one side and “MIA” on the other side, and they are distributed in a white bottle with black writing and “30 mg” highlighted yellow.
The description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211″ on the other side.
Products were distributed nationwide through pharmacies.
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, according to the FDA. Patients who unknowingly consume carbinoxamine could experience adverse events that include, but are not limited to, drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction and thyroid disorder.
For patients with ADHD and/or narcolepsy, 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…
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