Recalls / Class II
Class IID-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.
- Brand name
- Alfuzosin Hydrochloride
- Generic name
- Alfuzosin Hydrochloride
- Active ingredient
- Alfuzosin Hydrochloride
- Route
- Oral
- NDC
- 47335-956
- FDA application
- ANDA079057
- Affected lot / code info
- Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
Why it was recalled
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.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 22,915 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-01-05
- FDA classified
- 2017-03-01
- Posted by FDA
- 2017-03-08
- Terminated
- 2018-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0502-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.