What Happened
On January 24, 2024, Azurity Pharmaceuticals, Inc. voluntarily recalled a single lot (Lot F230169A, NDC 24338‑856‑03, expiry June 2025) of Zenzedi® (dextroamphetamine sulfate) 30 mg tablets, distributed nationwide through U.S. pharmacies U.S. Food and Drug Administration+12U.S. Food and Drug Administration+12Louisiana Department of Health+12.
Why the Recall Was Issued
A Nebraska pharmacist discovered that a bottle labeled as Zenzedi® contained Carbinoxamine Maleate tablets—an antihistamine with sedating effects—instead of the stimulant intended for ADHD and narcolepsy treatment health.gov.tt+5U.S. Food and Drug Administration+5express-scripts.com+5. This mislabeling could lead to:
- Under‑treatment of ADHD or narcolepsy
- Sedation, drowsiness, central nervous system depression
- Additional risks like increased eye pressure, urinary obstruction, and thyroid issues
- Potential hazards when operating vehicles or machinery—especially dangerous for patients expecting a stimulant effect express-scripts.comhttps://www.kbtx.com+4U.S. Food and Drug Administration+4Louisiana Department of Health+4
To date, no serious adverse events have been reported NBC Los Angeles+9U.S. Food and Drug Administration+9Louisiana Department of Health+9.
How to Identify Recalled Zenzedi® 30 mg Tablets
- Tablet appearance: light yellow, hexagonal, debossed with “30” on one side and “MIA” on the other
- Bottle label: white bottle with black print, “30 mg” highlighted in yellow
- Contrast: Carbinoxamine maleate tablets are described as white, round, with imprints “GL” on one side and “211” on the other Azurity Pharmaceuticals+6U.S. Food and Drug Administration+6https://www.kbtx.com+6.
Distribution Timeline
The recalled lot was shipped to wholesalers between August 23, 2023, and November 29, 2023 express-scripts.com+5U.S. Food and Drug Administration+5https://www.kbtx.com+5.
What Consumers Should Do
- Stop using the medication if it matches the description above
- Return the product to the place of purchase
- Contact your healthcare provider if you’ve taken the affected medication or experienced any problems
- Report adverse reactions or quality issues:
- To Azurity at aereports@azurity.com or call 800‑461‑7449 (Mon–Fri, 9 AM–5 PM EST)
- Via FDA’s MedWatch program online or by mail/fax X (formerly Twitter)+8U.S. Food and Drug Administration+8Louisiana Department of Health+8Prime Therapeutics
How the Recall Was Handled
Azurity sent recall notifications to wholesale distributors via overnight delivery starting January 4, 2024, and coordinated returns through Inmar Intelligence in Texas Louisiana Department of Health+3U.S. Food and Drug Administration+3https://www.kbtx.com+3. The FDA has since confirmed the recall is complete and formally terminated Azurity Pharmaceuticals.
🧠 Key Takeaways
| Risk | Description |
|---|---|
| Medication mix-up | Patients expecting a stimulant may instead receive a sedative, risking poor symptom control and increased accident or injury risk |
| Single lot issue | Only Lot F230169A affected; no wider contamination reported |
| No serious harm reported | As of recall announcement, no known injuries directly linked |
| Importance of vigilance | Pharmacists and patients both play roles in catching these mistakes early |
Why This Matters
Mistakes in dosage or drug identity can have severe consequences—especially when substituting a sedating antihistamine for a stimulant. ADHD and narcolepsy patients rely on precise dosing to function safely and effectively. This recall illustrates the critical importance of rigorous manufacturing quality control, clear labeling, and a robust pharmacovigilance system.
Final Thoughts
Even a single lot error can trigger a nationwide recall with significant patient impact. While limited in scope, this incident should remind healthcare providers and patients alike to verify packaging and physical appearance of medications. If in doubt, consult a pharmacist or medical professional immediately.
Discover more from सुदर्शन
Subscribe to get the latest posts sent to your email.