Zenzedi CII 30 mg Tablets Recalled Over Mislabeling Concerns

Azurity Pharmaceuticals, Inc. has issued a voluntary recall of 1 lot of Zenzedi CII 30 mg tablets. The decision comes in response to a report from a Nebraska pharmacist who discovered carbinoxamine maleate, an antihistamine, in a bottle labeled as Zenzedi 30 mg tablets. Azurity opened a product complaint and an investigation following the incident report.

At the time of Azurity’s January 25 announcement, it had not received reports of serious adverse events related to this recall.

Patients inadvertently consuming carbinoxamine maleate instead of Zenzedi may experience undertreatment of symptoms, posing an increased risk of accidents or injuries. Patients could also experience adverse events, which include drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.

For patients with attention-deficit/hyperactivity disorder (ADHD) or narcolepsy, the sedating effects of carbinoxamine could lead to ongoing disability or, in severe cases, death, “particularly if individuals who use it (unaware that they have not received Zenzedi) engage in activities requiring significant focus and alertness (eg, driving, operating heavy machinery),” the company stated in the press release.

Azurity has notified wholesalers and retailers, arranging for the return and replacement of the recalled product. Consumers in possession of the affected lot are urged to stop using it and return it to the place of purchase. Azurity has enlisted Inmar Intelligence for recall facilitation.

Identifying the Tablets

Zenzedi 30 mg tablets are light yellow and hexagonal in shape, debossed with "30" on one side and "MIA" on the other. The product NDC No is 24338-856-03, the lot number is F230169A, with a June 2025 expiration date, and was shipped to wholesalers between August 23 and November 29, 2023.

The suspect carbinoxamine tablets are white, round, and imprinted with "GL" on one side and "211" on the other. This product was distributed nationwide through pharmacies.

Further Information and Reporting Adverse Reactions

For further information, the manufacturer urged consumers to contact Inmar Intelligence for the recall process. Patients experiencing problems related to the use of Zenzedi should contact their health care provider. Adverse reactions can be reported to Azurity via email and to the FDA's MedWatch Adverse Event Reporting Program online, by mail, or fax.

Reference

US Food and Drug Administration. Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing. Published online January 25, 2024. Accessed January 29, 2024.