FDAHealthJuly 9, 2024
SUN PHARMACEUTICAL INDUSTRIES INC — Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmaci
⚠️ Failed Dissolution Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 9, 2024
Nationwide in the USA and Puerto rico
What's affected?
- 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
- NITROFURANTION
- UPC
- 0357664232187
- Lot code
- 231067
Additional details
Lot #s: 231067, 231069, Exp 04/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5752 bottles.
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