D-1387-2019 Class II Terminated
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
- 9528 30 count units
Product Description
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
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: GKT0484B, EXP 04/2020