Drug 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.
D-0597-2024
Product summary
- Event
- Event 94950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5752 bottles
- Official record key
drug-enforcement:D-0597-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #s: 231067, 231069, Exp 04/30/2025
Distribution pattern: Nationwide in the USA and Puerto rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications