D-0386-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 26, 2022
- Initiation Date
- January 4, 2022
- Termination Date
- October 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,536 boxes
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.