United StatesChlorthalidone Tablets, USP 25 mg in 100‑tablet (NDC 64980‑599‑01, Batch RISA24001) and 1000‑tablet (NDC 64980‑599‑10, Batch RISB24002) bottles, manufactured by Inventia Healthcare Limited and distributed by Risiong Pharma Holdings, Inc., exp. 04/2027, are being recalled nationwide in the U.S. The recall affects 11,460 bottles because the listed batches failed dissolution specifications.
What's being recalled
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
Recalling firm: Inventia Healthcare Limited, Kalyan, India.
How to identify it
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
The hazard
Failed Dissolution Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)