HEALTH
ADHD, Narcolepsy Drug Recalled Because Bottles May Contain Wrong Drug
Azurity Pharmaceuticals
Azurity Pharmaceuticals is recalling a medication used to treat narcolepsy and ADHD for mislabeled packaging after a pharmacist reported a bottle contained the wrong pills.
The drugmaker is recalling one lot of Zanzedi 30 mg tablets with lot number F230169A and an expiration date of June 2025.
Azurity said it received a report from a pharmacist in Nebraska who opened a bottle of the recalled pills and found that instead of Zanzedi, the bottle contained carbinoxamine maleate tablets, an antihistamine used to treat allergies.
Patients with attention deficit hyperactivity disorder (ADHD) or narcolepsy, a sleeping disorder that causes patients to feel tired during the day and fall asleep suddenly, who mistakenly take carbinoxamine maleate will experience undertreatment of their real symptoms, which could lead to adverse events, accidents or injuries.
ADHD and narcolepsy patients who unknowingly consume carbinoxamine could experience drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.
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 if individuals who use it (unaware that they have not received Zenzedi) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery), the company said.
Azurity said that to date, it has not received any reports of serious adverse events related to the 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 yellow.
The suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), were described by the reporting pharmacist as white round tablets with imprints of “GL” on one side and “211” on the other side.
The recalled medication was distributed nationwide through pharmacies. The company said it was already working with wholesalers and retailers to return unsold product. Consumers who may have already received the recalled medication should contact their physician or healthcare provider if they have experienced any problems related to the recalled product.
TMX contributed to this article.
