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
Reported: June 26, 2019 Initiated: June 5, 2019 #D-1387-2019
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
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 9528 30 count units
- Distribution
- Nationwide in the USA
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 9528 30 count units.
Why was this product recalled? ▼
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2019. Severity: Moderate. Recall number: D-1387-2019.
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