Drug product
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
D-0610-2026
Product summary
- Event
- Event 99136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,460 bottles
- Official record key
drug-enforcement:D-0610-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications