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FDANovember 12, 2021drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed dissolution specifications

What to do

FDA enforcement status: Terminated

Brands named

dr reddy s laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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