Last Updated on February 17, 2024 by The Health Master
Drug recall
Summary of the drug recall is as under:
- Company Announcement Date: January 24, 2024
- USFDA Publish Date: January 25, 2024
- Product Type: Drugs
- Reason for Announcement: Mislabeled package
- Company Name: Azurity Pharmaceuticals, Inc.
- Brand Name: Zendedi
- Product Description: Dextroamphetamine sulfate tablets, 30 mg
Company Announcement
Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level.
The drug recall is 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.
Advisory for patients
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.
Indication
Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand.
Reason for drug 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.
Product was distributed nationwide through pharmacies.
Product detail
| Product | NDC No. | Lot No. | Exp. Date | Ship Dates to Wholesalers |
|---|---|---|---|---|
| Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg | 24338-856-03 | F230169A | 2025-06 | 08/23/2023 – 11/29/2023 |
Azurity Pharmaceuticals, Inc. sent drug recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level.
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. Azurity has enlisted the services of Inmar Intelligence to facilitate the drug recall.
Inmar is located at 3845 Grand Lakes Way, Grand Prairie, TX 75050. All returns from wholesalers and retailers must go to Inmar at this address.
This drug recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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