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U.S. Department of Health and Human Services

Enforcement Report - Week of March 9, 2016

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Product Detail

Product Description Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Recall Number D-0735-2016
Classification Class II
Code Info Lot #s: JKP2234A, JKP2235A, Exp 04/17
Product Distributed Qty 381,120 cartons
Reason For Recall Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.

Event Detail

Event Id 73420
Product Type Drugs
Status Ongoing
Recalling Firm Sun Pharma Global Fze
City Sharm
Country AE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2016-02-11
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide and Puerto Rico