FDA recall D-0502-2017

Product

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.

Reason for recall

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.

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-01-05

Report date

2017-03-08

Termination date

2018-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0502-2017