FDA-Drug2021-12-15Class III

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.

Dr. Reddy's Laboratories, Inc.
Hazard

Failed dissolution specifications

Sold states
USA Nationwide.
Affected count
2496 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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.

Official notice

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

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