FDA-Drug2017-03-08Class II
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.
Sun Pharmaceutical Industries, Inc.
Hazard
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.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
22,915 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0502-2017Don't want to check this manually?
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