Why it was recalled
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Product description
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
Lot numbers, UPCs & expiration codes
CP0761501, Exp. 12/16
Where it was sold
Nationwide and PR
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-1405-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 20, 2015
- FDA report date
- Sep 9, 2015
- Quantity
- 21552 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1405-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 71776
- Address
- 120 Vintage Dr NE
- Code information
- CP0761501, Exp. 12/16
- Postal code
- 35811-8216
- Report date
- Sep 9, 2015
- Product type
- Drugs
- Recall number
- D-1405-2015
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 21552 units
- Termination date
- Mar 7, 2016
- Reason for recall
- Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
- Distribution pattern
- Nationwide and PR
- Recall initiation date
- Jul 20, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 1, 2015