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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65511
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 Lot: LF01213A, Exp. 02/14 Class II Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. 10,848 cartons D-805-2013
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