TOPIC: Zenzedi (dextroamphetamine sulfate tablets) USP, 30 mg by Azurity Pharmaceuticals: Recall - Due to a Mislabeled Package During Manufacturing
AUDIENCE: Patient, Health Professional, Pediatrics, Psychiatry, Pharmacy
ISSUE: Azurity Pharmaceuticals is recalling one lot F230169A of Zenzedi CII (dextroamphetamine sulfate tablets) USP, 30 mg due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.
Patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. 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. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is 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 (e.g., driving, operating heavy machinery).
To date, Azurity has not received any reports of serious adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Zenzedi is a prescription medicine for the treatment of Narcolepsy and is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD).
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. An adverse event may also be reported to Azurity via email at aereports@azurity.com.
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Consumers that have product which is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product.
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