Azurity Pharmaceuticals, a Massachusetts-based company, has announced a voluntary recall of one lot of Zenzedi 30 mg tablets, a medication used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. The recall was initiated after a pharmacist in Nebraska discovered that a bottle labeled as Zenzedi contained carbinoxamine maleate, an antihistamine used to treat allergies. The company said it has not received any reports of adverse events or injuries related to the mix-up.
Why is it dangerous?
Zenzedi is a stimulant that contains dextroamphetamine sulfate, a controlled substance that affects the central nervous system. It helps people with ADHD and narcolepsy to improve their attention, focus, and alertness. Carbinoxamine maleate, on the other hand, is a sedative that causes drowsiness, sleepiness, and central nervous system depression. It also increases eye pressure, enlarges prostate, and affects thyroid function. Taking carbinoxamine instead of Zenzedi could have serious consequences, such as increased risk of accidents, injuries, and impaired cognitive and physical performance.
How to identify the recalled product?
The recalled lot of Zenzedi 30 mg tablets has the lot number F230169A and an expiration date of June 2025. The product was distributed nationwide through pharmacies. The company advises consumers who have the recalled product to return it to their pharmacy immediately and contact their health care provider if they have any concerns or questions. They can also report any problems to the FDA’s MedWatch Adverse Event Reporting program.
What is the company doing?
Azurity Pharmaceuticals said it is investigating the cause of the error and taking corrective actions to prevent it from happening again. The company also said it is working closely with the FDA and other regulatory agencies to ensure the safety and quality of its products. The company apologized for any inconvenience and inconvenience caused by the recall and thanked its customers for their cooperation.
What is the status of ADHD drugs supply?
The recall of Zenzedi comes amid a national shortage of ADHD drugs that has been ongoing since October 2022. The shortage has affected several brands and generics of stimulants and non-stimulants, such as Adderall, Ritalin, Concerta, Strattera, and Vyvanse. The reasons for the shortage are complex and multifactorial, involving manufacturing delays, supply chain disruptions, increased demand, and regulatory hurdles. The shortage has created frustration and uncertainty for people with ADHD who rely on these medications to manage their symptoms and improve their quality of life.
