FDA recall D-0386-2022

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

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

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-01-04
Report date: 2022-01-26
Termination date: 2023-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2022