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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65877
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36 Lots: LF01643C, LF01644C, Exp 7/14 Class III Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card 8, 681 unit cartons D-854-2013