Alfuzosin Hydrochloride Extended-release Tablets recalled over foreign material

Recall date

January 5, 2017

Source

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

Official notice title

Sun Pharmaceutical Industries, Inc. recalls Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical…

Recall number

D-0502-2017

FDA classification

Class II

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

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

What was recalled

Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.