The antihistamine drug carbinoxamine was found in one bottle Zenzedi, which is used to treat narcolepsy and ADHD.
Azurity Pharmaceuticals is recalling one of Zenzedi CII (dextroamphetamine sulfate tablets) 30 mg, which used to treat patients with narcolepsy, as well as attention deficit hyperactivity disorder. A pharmacist reported finding carbinoxamine maleate, an antihistamine drug, in a bottle of Zenzedi. Zenzedi is marketed by Arbor Pharmaceuticals, a subsidiary of Azurity.
Patients who take carbinoxamine instead of Zenzedi could experience drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. To date, Azurity has not received any reports of serious adverse events related to this recall.
Zenzedi has an NDC number of 24338-856-03. The lot involved in the recall is F230169A with an expiration date of June 2026. It was shipped between Aug. 23, 2023, and Nov. 29, 2023.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More