Drug 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.
Lots and codes
Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 22,915 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 5, 2017
- Terminated
- June 29, 2018
Related products
- Alfuzosin Hydrochloride – drug information
- NDC 47335-956 Alfuzosin Hydrochloride · Alfuzosin Hydrochloride 10 mg/1 · Sun Pharmaceutical Industries, Inc.