Home / Recalls / Sandoz Incorporated / D-854-2013

D-854-2013 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
August 14, 2013
Initiation Date
August 7, 2013
Termination Date
July 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8, 681 unit cartons

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

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

Distribution Pattern

Nationwide

Code Information

Lots: LF01643C, LF01644C, Exp 7/14

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