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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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
Recall Number D-854-2013
Classification Class III
Code Info Lots: LF01643C, LF01644C, Exp 7/14
Product Distributed Qty 8, 681 unit cartons
Reason For Recall 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

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 Letter
Distribution Pattern Nationwide