Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Dist…
- Recall date
- June 5, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1387-2019
- FDA classification
- Class II
- Brand / firm
- Sun Pharmaceutical Industries, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
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