FDAFDA · Food and drugs·Recall number D-854-2013
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
Published August 14, 2013 · Recall initiated: August 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Incorporated
- Distributor
- Nationwide
- Lot
- Lots: LF01643C, LF01644C, Exp 7/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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