Why it was recalled
Failed dissolution specifications
Product description
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
Lot numbers, UPCs & expiration codes
Lot #: AC2103329A
Where it was sold
USA Nationwide.
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-0275-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 12, 2021
- FDA report date
- Dec 15, 2021
- Quantity
- 2,928 cartons
- Recall type
- N/A
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0275-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89042
- Address
- 107 College Rd E
- Code information
- Lot #: AC2103329A
- Postal code
- 08540-6623
- Report date
- Dec 15, 2021
- Product type
- Drugs
- Recall number
- D-0275-2022
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2,928 cartons
- Termination date
- Jun 23, 2023
- Reason for recall
- Failed dissolution specifications
- Product description
- Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Nov 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 7, 2021