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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
Recall Number D-66458-1
Classification Class II
Code Info Lot DJ2744, Exp 12/2014
Product Distributed Qty 692 bottles (90 count)
Reason For Recall Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

Event Detail

Event Id 66458
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz, Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide