FDA (Drugs) recall action 83025
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
The agency’s own wording, quoted from the enforcement report.
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.
Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.
Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion tablets because testing showed impurity levels above or near specification limits.