Drug 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
D-1387-2019
Product summary
- Event
- Event 83025
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9528 30 count units
- Official record key
drug-enforcement:D-1387-2019
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: GKT0484B, EXP 04/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications