Drug recall D-1388-2019

Class II Terminated reported Jun 26, 2019

Product

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1

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

Lots and codes

Lot GKT0791, EXP 06/2020

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
17,136 20-count units
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
June 5, 2019
Terminated
January 8, 2021