Drug recall D-1390-2019

Class II Terminated reported Jun 26, 2019

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

Reason for recall

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Lots and codes

Lot GKT0406, EXP 3/2020

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
17,904 20-count units
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
June 5, 2019
Terminated
January 8, 2021