Medicine recalls
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| The United States: Azurity Pharmaceuticals, Inc. issues voluntary nationwide recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg due to a mislabeled package during manufacturing |
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The US Food and Drug Administration (FDA) announces that Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg (lot number: F230169A) to the consumer level. The product is being recalled due to a report from a pharmacist 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 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.
Zenzedi® 30 mg tablets can be identified by 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 yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-zenzedir-dextroamphetamine-sulfate
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jan 26, 2024
Issued at HKT 15:00
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