Drug recall D-1389-2019

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, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7

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: GKS1014, EXP 09/2019; GKT0484A, EXP 04/2020

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
14,399 30-count units
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
June 5, 2019
Terminated
January 8, 2021