January 2017 FDA Recall Alfuzosin Hydrochloride by Sun Pharmaceutical Industries, Inc.
D-0502-2017 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on January 5, 2017 for the product Alfuzosin Hydrochloride. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0502-2017

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.
Initiated
01-05-2017
Reported
03-08-2017
Quantity
22,915 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76543
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2018
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18

Affected Packages Involved in this Recall

47335-956-83 Alfuzosin Hydrochloride
47335-956-81 Alfuzosin Hydrochloride
47335-956-88 Alfuzosin Hydrochloride
47335-956-08 Alfuzosin Hydrochloride
47335-956-18 Alfuzosin Hydrochloride