Drug recall D-0597-2024
Product
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
Reason for recall
Failed Dissolution Specifications
Lots and codes
Lot #s: 231067, 231069, Exp 04/30/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 5752 bottles
- Distribution
- Nationwide in the USA and Puerto rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 9, 2024
- Terminated
- December 22, 2025
Related products
- Nitrofurantion – drug information
- NDC 57664-231 Nitrofurantion · Nitrofurantoin 25 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-232 Nitrofurantion · Nitrofurantoin 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-233 Nitrofurantion · Nitrofurantoin 100 mg/1 · Sun Pharmaceutical Industries, Inc.