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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 66402
Product Type Drugs
Status Ongoing
Recalling Firm Tolmar, Inc.
City Fort Collins
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04. Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14 Class III Subpotent 391,055 bottles D-66402-001
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