SUN PHARMACEUTICAL INDUSTRIES INC recalls Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborat…

Recall date

July 9, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0597-2024

FDA classification

Class II

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

Nationwide in the USA and Puerto rico

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.