ADHD Drug Recall as Mislabeled Package Sparks Warning

Zenzedi, an attention-deficit/hyperactivity disorder (ADHD) drug, has been recalled after a mislabeled package sparked a warning for prescribers of the medication.

Azurity Pharmaceuticals, Inc. announced the recall of one lot (F230169A) of Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 milligrams on Wednesday, which the U.S. Food and Drug Administration (FDA) put on its website on Thursday. The recalled lot was shipped to wholesalers from August 23, 2023, to November 29, 2023.

In the announcement, Azurity Pharmaceuticals said that a pharmacist in Nebraska reported opening a bottle of Zenzedi only to find tablets of Carbinoxamine Maleate, which is an antihistamine drug. Following the report, the drug manufacturer opened a product complaint, which was proceeded by an investigation.

Zenzedi 30 mg tablets are light yellow and shaped like a hexagon. It has the number 30 on one side and the letters MIA on the other side. Meanwhile, Carbinoxamine Maleate tablets USP, 4 mg, which were found by the pharmacist, are white and round, with the number 211 on one side and the letters GL on the other.

In addition to ADHD, Zenzedi is used to treat narcolepsy, a sleeping disorder. Azurity Pharmaceuticals warned in its release that "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."

It also warned that for ADHD and narcolepsy patients "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..."

The pharmaceuticals company listed the following adverse events that patients who unknowingly took carbinoxamine may experience:

• Drowsiness
• Sleepiness
• Central nervous system (CNS) depression
• Increased eye pressure
• Enlarged prostate urinary obstruction
• Thyroid disorder

Newsweek reached out to Azurity Pharmaceuticals via telephone for comment.

Meanwhile, Azurity Pharmaceuticals reassured its consumers that there has yet to be any reports of "serious adverse events" involving the drug recall.

The company warned consumers who have the recalled drug to stop using it and return it to where they purchased it from. Additionally, it said that "consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product."

Those who experience an adverse event can contact Azurity Pharmaceuticals and the FDA's MedWatch Adverse Event Reporting program. Quality problems may also be reported to the FDA's program. To contact the FDA's program, call 1-800-332-1088 or go to www.fda.gov/medwatch/report.htm.

Azurity Pharmaceuticals notified wholesale distributors of the recall on January 4. The company said in its release that it "is working with wholesalers and retailers to arrange for the return and replacement of recalled product."