D-1390-2019 Class II Terminated

Recalled by Sun Pharmaceutical Industries, Inc. — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
June 26, 2019
Initiation Date
June 5, 2019
Termination Date
January 8, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,904 20-count units

Product Description

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot GKT0406, EXP 3/2020