D-0502-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- January 5, 2017
- Termination Date
- June 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,915 bottles
Product Description
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 Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18