Recalls / Class II
Class IID-1389-2019
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
- Affected lot / code info
- Lot: GKS1014, EXP 09/2019; GKT0484A, EXP 04/2020
Why it was recalled
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 14,399 30-count units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-06-05
- FDA classified
- 2019-06-14
- Posted by FDA
- 2019-06-26
- Terminated
- 2021-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1389-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.