FDA Notice: Prescription Drugs Recalled After Dangerous Label Mix-Up

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

A pharmaceutical company issued a nationwide recall of a medication due to mislabeled packaging, according to a notice published by the U.S. Food and Drug Administration (FDA).

Massachusetts-based Azurity Pharmaceuticals recalled one lot of Zenzedi CII dextroamphetamine sulfate tablets last week, which was shipped between Aug. 23 and Nov. 29, 2023. The drug can be used to treat narcolepsy and attention-deficit-hyperactivity disorder (ADHD), although it is sometimes abused and can be addictive, according to federal health officials.

The notice, posted to the FDA’s website, said that a pharmacist in Nebraska reported opening a bottle of Zenzedi to find tablets of carbinoxamine maleate, an antihistamine drug, in a bottle.

“Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder,” it said.

Patients who are using the drug for narcolepsy and ADHD can have 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, particularly if individuals who use it (unaware that they have not received Zenzedi) engage in activities requiring significant focus and alertness,” including operating heavy machinery, driving, and other activities.

So far, the company has not received any reports of adverse events in connection to the recall.

The Zenzedi tablets that are impacted come in 30 milligrams and light yellow as well as hexagonal. There is a “30” printed on one side and “MIA” on the other side of the tablet. It is sometimes distributed in a white bottle with “30 mg” highlighted in yellow and in black writing, according to the notice.

Carbinoxamine maleate tablets white and round with imprints of “211” and “GL” on either side.

According to the FDA announcement, the lot of Zenzedi is F230169A with an expiration date of 2025 to 2026. The drug has an National Drug Code number of 24338-856-03, it says.

Azurity said that it had wholesale distributors of the recall Jan. 4, 2024. However, those who still have he products are advised to stop using them and return them to the place of purchase, according to the notice.

Other FDA Activity

It comes several days after the maker of Robitussin cough syrup is recalling several lots of products containing honey due to contamination that could pose a serious risk to people with weakened immune systems.

The recall covers eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult, which were distributed to stores and pharmacy suppliers. The FDA posted the company’s announcement to its website Wednesday.

The products may contain dangerously high levels of yeast, the company said in an emailed message to The Associated Press last Thursday. Yeast is a natural component of honey, but the levels detected by the company were “beyond allowed measurements,” maker Haleon said.

Ingestion of the contaminated syrup could result in severe fungal infections that would be potentially dangerous for people with weakened immune systems, such as organ transplant recipients or those with HIV. Several million people in the United States have conditions that impair the immune system’s ability to fight off infections.

On Jan. 22, the FDA issued a new warning regarding supplements that contain the ingredient tianeptine, sometimes called “gas station heroin,” sold under the brand Neptune’s Fix. The products, it said, are linked to side effects such as seizures, a loss of consciousness, and even death.

Tianeptine is an antidepressant approved in some Asian, Latin American, and European counties. It’s not approved in the United States by the FDA, however.

It is sometimes found in the United States illegally in supplements billed to “improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” according to the FDA notice.

The Associated Press contributed to this report.