Azurity Recalls Zenzedi
The company issued the recall because of a package mislabeling problem.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
On Jan. 24, 2024, Azurity Pharmaceuticals, a Woburn, Mass., company, issued a voluntary recall of one lot of Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg because the incorrect product was found in the bottle. Tablets of Carbinoxamine Maleate, an antihistamine drug, were found in the Zenzedi bottle by a pharmacist in Nebraska.
The recalled lot, F230169A, was shipped to wholesalers from Aug. 23, 2023 to Nov. 29, 2023 and has an expiration date of June 2025. It is marketed under the Arbor Pharmaceuticals brand. Zenzedi 30 mg tablets are a light yellow, hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted in yellow. Carbinoxamine Maleate Tablets USP, 4 mg, are white round tablets with imprints of “GL” on one side and “211” on the other side.
Zenzedi is used to treat narcolepsy and attention deficit hyperactivity disorder. According to the company, patients may experience symptom undertreatment and increased risk of accidents if they take carbinoxamine instead of Zenzedi. Unknowingly consuming carbinoxamine may result in drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder, according to the company. Carbinoxamine may also cause sedation, which could lead to disability or accidents.
The company has sent recall notifications to wholesale distributors. Consumers should stop using the recalled product and return it to where it was purchased. Azurity has not received reports of adverse events as a result of the recall. Adverse events may be reported to FDA via its MedWatch program.
Source: FDA
