FDA recall D-0272-2022

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

Product

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.

Reason for recall

Failed dissolution specifications

Distribution

USA Nationwide.

Key facts

Status: Terminated
Initiation date: 2021-11-12
Report date: 2021-12-15
Termination date: 2023-06-23
Voluntary/Mandated: N/A
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0272-2022