FDA-Drug2024-07-24Class II

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.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA and Puerto rico
Affected count
5752 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2024

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