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ADHD medication recalled due to labelling mishap

ADHD medication recalled due to labelling mishap

A drug manufacturer is voluntarily recalling one of its medications – Zenzedi – that treats ADHD and narcolepsy due to mislabeled packaging amid a year-and-a-half-long stimulant shortage.

The recall notice, posted on 24 January, stated that Azurity Pharmaceuticals is recalling its 30mg tablets of Zenzedi after a pharmacist in Nebraska discovered that a bottle labelled as containing Zenzedi actually contained an antihistamine called carbinoxamine maleate.

The FDA noted that ADHD or narcolepsy patients who were prescribed Zenzedi and accidentally took the antihistamine “will experience undertreatment of their symptoms”.

While Zenzedi is a stimulant, carbinoxamine maleate could cause drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder, the FDA warned.

The agency said that the 30mg tablets of Zenzedi look like light yellow hexagonal tablets marked with “30” on one side and “MIA” on the other.

Zenzedi recalled after labelling mishap (FDA)
Zenzedi recalled after labelling mishap (FDA)

The Nebraska pharmacist described the carbinoxamine maleate tablets as white round tablets with imprints of “GL” on one side and “211” on the other side.

The FDA warned consumers who have the recalled medication to stop using it and return the medication to where they obtained it.

Azurity sent recall notification letters to wholesale distributors on 4 January, the agency said, and “arranged for the return of all recalled products at that wholesaler level”.

The recall comes as a stimulant shortage has persisted since October 2022. The shortage has sparked a crisis across the US, affecting millions of adults and children.

Ever since the FDA announced that there was a scarcity of Adderall in October 2022, a domino effect of shortages has ensued. People were forced to switch from Adderall to other medications, leading to shortages in Vyvanse in July 2023 followed by a methylphenidate (Concerta and Ritalin) shortage days later.