It’s one thing for a drugmaker to recall a product after a labeling mix-up, but it’s another situation entirely when the wrong drug turns up in a bottle of branded medicine.
Azurity Pharmaceuticals is recalling one batch of Zenzedi 30mg tablets from U.S. shelves after it received a report from a pharmacist in Nebraska who opened a bottle of the narcolepsy treatment and instead found carbinoxamine maleate, an antihistamine drug.
After receiving word of the mix-up, Azurity kicked off an investigation and is pulling one drug lot.
Zenzedi is indicated for both narcolepsy and ADHD and marketed under Azurity’s subsidiary Arbor Pharmaceuticals.
The suspect batch was shipped to wholesalers between late August and late November of 2023. The lot was due to expire in June 2025.
Since antihistamine drugs can cause drowsiness, narcolepsy patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, Azurity said in a notice posted on the FDA’s website.
Patients who unknowingly consume the antihistamine drug could experience other side effects such as drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction and thyroid disorder.
What’s more, patients who have both attention deficit hyperactivity disorder (ADHD) and narcolepsy have a “reasonable probability” of experiencing accidents or injuries thanks to the sedating effects of carbinoxamine, which could lead to ongoing disability or death in severe cases, Azurity said.
As of Wednesday, Azurity hadn’t received any side effects or safety reports linked to the recall.
Labeling mix-ups can have serious consequences for patients, but they happen more often than one might think.
Back in December, Glenmark Pharmaceuticals issued two separate Class II recalls due to mislabeling issues involving indomethacin and naproxen. The company specifically pulled 37,200 bottles of indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms.
Separately, the drugmaker recalled five lots of naproxen, which is used to reduce fever or relieve mild pain due to headaches, muscle aches and other minor maladies.
Both products may have been mislabeled as the other, Glenmark said.