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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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
Recall Number D-805-2013
Classification Class II
Code Info Lot: LF01213A, Exp. 02/14
Product Distributed Qty 10,848 cartons
Reason For Recall Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

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.
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