The Recall Desk

FDA (Drugs) recall action 83025

Sun Pharmaceutical Industries, Inc. recalled 4 products on 2019-06-26

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.

Products
4
Announced
2019-06-26
Critical
0
Units
—

Why these products were recalled

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.

1–4 of 4

  • ModerateFDA (Drugs)··2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.

    Product
    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
    Category
    Distribution
    0 states