Recalls / Class III
Class IIID-1405-2015
Product
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
- Brand name
- Allopurinol
- Generic name
- Allopurinol
- Active ingredient
- Allopurinol
- Route
- Oral
- NDCs
- 0603-2115, 0603-2116
- FDA application
- ANDA075798
- Affected lot / code info
- CP0761501, Exp. 12/16
Why it was recalled
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 21552 units
- Distribution pattern
- Nationwide and PR
Timeline
- Recall initiated
- 2015-07-20
- FDA classified
- 2015-09-01
- Posted by FDA
- 2015-09-09
- Terminated
- 2016-03-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1405-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.