D-0597-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 24, 2024
- Initiation Date
- July 9, 2024
- Termination Date
- December 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5752 bottles
Product Description
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
Distribution Pattern
Nationwide in the USA and Puerto rico
Code Information
Lot #s: 231067, 231069, Exp 04/30/2025