FDA recall D-1389-2019

Sun Pharmaceutical Industries, Inc. · Class II · 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

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

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-06-05
Report date: 2019-06-26
Termination date: 2021-01-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1389-2019