Recall alert: ADHD drug mislabeled; antihistamine sent in bottle with Zenzedi label

Azurity Pharmaceuticals, Inc. is recalling one lot of the drug Zenzedi after it was found to have been mislabeled.

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A pharmacist reported that a drug in the bottle labeled Zenzedi – which is a drug used to treat Attention Deficit Hyperactivity Disorder and narcolepsy – was instead carbinoxamine maleate, an antihistamine.

Patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, according to the U.S. Food and Drug Administration.

Undertreatment could result in functional impairment and an increased risk of accidents or injury, the agency said in a news release.

“Patients who unknowingly consume 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.”

To date, Azurity has not received any reports of serious adverse events related to this recall.

Zenzedi 30 mg tablets are light yellow hexagonal tablets debossed with “30″ on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted in yellow.

Carbinoxamine Maleate tablets are white round tablets with imprints of “GL” on one side and “211″ on the other side. The product was distributed nationwide through pharmacies.

The affected lot of Zenzedi is F230169A with an expiration date of 2025-06. The NCD number is 24338-856-03.

For more information on the recall, call Inmar Intelligence at 877-804-2069, Monday through Friday, 9 a.m.-5 p.m. EST.

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