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Product Mix Up Leads to Recall of Narcolepsy Drug Zenzedi
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 Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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