drugs Class III Updated 2013-08-14

Sandoz Incorporated recalls Introvale (levonorgestrel and ethinyl estradiol) tablets, US

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: LF01643C, LF01644C, Exp 7/14
View official government recall

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