Recalls / Class II
Class IID-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.
- Brand name
- Nitrofurantion
- Generic name
- Nitrofurantion
- Active ingredient
- Nitrofurantoin
- Route
- Oral
- NDCs
- 57664-231, 57664-232, 57664-233
- FDA application
- ANDA201722
- Affected lot / code info
- Lot #s: 231067, 231069, Exp 04/30/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 5752 bottles
- Distribution pattern
- Nationwide in the USA and Puerto rico
Timeline
- Recall initiated
- 2024-07-09
- FDA classified
- 2024-07-12
- Posted by FDA
- 2024-07-24
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0597-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.