Why it was recalled
Failed Dissolution Specifications
Product description
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Lot numbers, UPCs & expiration codes
Lot #s: 79C002624D; 79C002625C, Exp. 4/30/2022.
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-0384-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 4, 2022
- FDA report date
- Jan 26, 2022
- Quantity
- 9,984 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0384-2022, 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: 79C002624D; 79C002625C, Exp. 4/30/2022.
- Postal code
- 08540-6623
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0384-2022
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 9,984 boxes
- Termination date
- Oct 20, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, 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