Class II
Terminated
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.
- Recall Initiated
- January 5, 2017
- Posted
- March 8, 2017
- Recall Number
- D-0502-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 22,915 bottles
- Firm Location
- Cranbury, NJ, United States
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.
Lot / Code Info
Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
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