Alfuzosin Hydrochloride Tablet, Extended Release
FDA Recall NDC 47335-956
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Alfuzosin Hydrochloride (NDC 47335-956). A significant event, classified as Class II, was initiated on Jan 05, 2017 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Jan 05, 2017
Mar 08, 2017
22,915 bottles
Recall Profile & Regulatory Data
Event ID
76543
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Jun 29, 2018
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.
Batch or Lot Expiration Information
Lot# : JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
Affected Packages Involved in this Recall
47335-956-83Product
47335-956-81Product
47335-956-88Product
47335-956-08Product
47335-956-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
