A popular medication for ADHD and narcolepsy has been recalled after the pharmaceutical company discovered that the bottles had been swapped for an antihistamine drug.
Azurity Pharmaceuticals announced that Zenzedi CII 30 mg tablets have been recalled after a pharmacist in Nebraska discovered that the bottles didn’t contain the ADHD pills; rather, the containers were filled with Carbinoxamine Maleate, an antihistamine.
Health risks with the swapped medications
According to the FDA’s official report, no adverse effects have been reported to Azurity since the mishap has been identified. However, it’s important for consumers to know that there are health risks associated with taking antihistamines versus Zenzedi.
“Patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, which result in functional impairment and an increased risk of accidents or injury,” the FDA explained. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”
The FDA also warned against accidents and injuries occurring, especially when driving or operating other types of machinery, when consumers unknowingly take the swapped medications.
What to avoid
The FDA has identified one lot of mismatched medications:
Zenzedi, 30 mg tablets
NDC # – 2433-856-03
Lot # – F230169A
Expiration date – June 2025
Ship dates to wholesalers – 8/23/2023 through 11/29/2023
To identify the pills as Zenzedi, they should be light yellow and hexagon in shape. One side should have “30” imprinted, and the other side should have “MIA.”
Similarly, carbinoxamine can be identified as: white, round tablets, “211” imprinted on one side, and “GL” imprinted on the other side.
Azurity has sent recall letters to all wholesalers, and the company is working with their partners to ensure all wrongly-labeled pills are returned. If consumers notice their pills have been labeled incorrectly, they are urged to stop taking the drugs immediately and return them to their pharmacy/wholesaler.
Any incidents related to this recall should be reported to the FDA’s MedWatch Adverse Reporting Events program here. Consumers should also contact their health care providers as soon as possible.
Photo Credit: Consumer Affairs News Department Images
Posted: 2024-01-30 14:01:06
