Recall D-0597-2024

US Class II Terminated · initiated 2024-07-09

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC, NJ

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.

Reason for recall

Failed Dissolution Specifications

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