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
Product description
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
Lot numbers, UPCs & expiration codes
Lot: GKS1014, EXP 09/2019; GKT0484A, EXP 04/2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1389-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 14,399 30-count units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-1389-2019, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83025
- Address
- 270 Prospect Plains Rd
- Code information
- Lot: GKS1014, EXP 09/2019; GKT0484A, EXP 04/2020
- Postal code
- 08512-3605
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1389-2019
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 14,399 30-count units
- Termination date
- Jan 8, 2021
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 5, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2019