Recalls / Class II
Class IID-0583-2024
Product
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.
- Brand name
- Allopurinol
- Generic name
- Allopurinol
- Active ingredient
- Allopurinol
- Route
- Oral
- NDCs
- 55111-729, 55111-730
- FDA application
- ANDA071586
- Affected lot / code info
- L2300594
Why it was recalled
Presence of foreign substance.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 20,520 units
- Distribution pattern
- IL, MS, OH
Timeline
- Recall initiated
- 2024-06-07
- FDA classified
- 2024-07-03
- Posted by FDA
- 2024-07-10
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0583-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.