ADHD/Narcolepsy Drug Recalled Due to Medication Mix-Up

The manufacturer of Zenzedi recalled one lot of the medication after a pharmacist discovered an antihistamine instead of the ADHD drug in the pill bottle.

On January 24, Azurity Pharmaceuticals, Inc. voluntarily recalled one lot of Zenzedi CII 30 mg after a Nebraska pharmacist opened a bottle of the drug and found it contained the antihistamine Carbinoxamine Maleate instead of Zenzedi.

Azurity says the drug was mislabeled during the manufacturing process.

According to the company's announcement, the lot number involved in the recall is F230169A, with an expiration date of June 2025. The mislabeled product was distributed to pharmacies nationwide.

Upon learning about the mix-up, Azurity Pharmaceuticals immediately contacted pharmacies and wholesalers, instructing them to return the recalled lot to the company.

Zenzedi (dextroamphetamine sulfate tablets, USP) is a stimulant medication used to treat narcolepsy, a condition that causes excessive daytime sleepiness. Clinicians also prescribe the drug to people with attention deficit hyperactivity disorder (ADHD).

Carbinoxamine Maleate is an antihistamine for treating seasonal or long-term allergies. In contrast to Zenzedi, carbinoxamine can cause drowsiness.

The FDA says that people with narcolepsy or ADHD who unknowingly take carbinoxamine could experience sleepiness, central nervous system depression, and other adverse effects due to its sedating properties. These effects could be dangerous and lead to harm or even death when engaging in activities that require intense focus and alertness, like driving.

However, the drug's manufacturer has not received any reports of serious events related to the medication mix-up.

People who take the Narcolepsy/ADHD drug can check their pill bottle to see if it contains Zenzedi, which is a light yellow hexagonal tablet with "30" stamped on one side and "MIA" on the other side.

Carbinoxamine antihistamine pills are white round tablets with imprints of "GL" on one side and "211" on the other.

Image of Zenzedi Tablets
Image of Zenzedi tablets courtesy of the FDA

Azurity says anyone taking Zenzedi who experiences issues with the medication should contact the company via email at [email protected]. In addition, people who have experienced any adverse events related to this product can report it to the FDA's MedWatch Adverse Event Reporting program.

Leave a reply

Your email will not be published. All fields are required.