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U.S. Department of Health and Human Services

Enforcement Report - Week of October 16, 2013

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Product Detail

Product Description Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
Recall Number D-66373-001
Classification Class III
Code Info Lot #: BU3417, Exp 06/2014
Product Distributed Qty 25,830 bottles
Reason For Recall Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

Event Detail

Event Id 66373
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide