The company issued the voluntary recall Jan. 24, after a pharmacist in Nebraska reported finding carbinoxamine maleate, an antihistamine, in a bottle of Zenzedi 30 milligram tablets. Azurity said it opened a product complaint and launched an investigation after learning of the incident.
The recalled lot — F230169A — was shipped to wholesalers between late August through November 2023.
“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 company said in its recall notice. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”
Azurity said it had not received reports of serious adverse events at the time of the recall.
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