Why it was recalled
Failed Dissolution Specifications
Product description
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
Lot numbers, UPCs & expiration codes
Lot #s: a) (20-count): AC2000968A; AC2000968F, Exp. 8/31/2022. b) (30-count): 79C002624B, Exp. 4/30/2022; AC2103330G; AC2103330H, Exp. 1/31/2023.
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-0385-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 4, 2022
- FDA report date
- Jan 26, 2022
- Quantity
- 41,784 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0385-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89364
- Address
- 107 College Rd E
- Code information
- Lot #s: a) (20-count): AC2000968A; AC2000968F, Exp. 8/31/2022. b) (30-count): 79C002624B, Exp. 4/30/2022; AC2103330G; AC2103330H, Exp. 1/31/2023.
- Postal code
- 08540-6623
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0385-2022
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 41,784 boxes
- Termination date
- Oct 20, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2022