FDAFDA · Food and drugs·Recall number D-0386-2022
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Published January 26, 2022 · Recall initiated: January 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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