Class III
Terminated
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.
This recall has been terminated (originally issued January 26, 2022).
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- January 4, 2022
- Posted
- January 26, 2022
- Recall Number
- D-0386-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,536 boxes
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide in the USA
Lot / Code Info
Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.
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