Drug 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
D-1389-2019
Product summary
- Event
- Event 83025
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,399 30-count units
- Official record key
drug-enforcement:D-1389-2019
Official wording
Reason: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Code information: Lot: GKS1014, EXP 09/2019; GKT0484A, EXP 04/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications