Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error
Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a packaging/sequencing error rather than a contamination or structural defect, fitting the criteria for a moderate severity score.
Plain-English summary
Sandoz Incorporated is voluntarily recalling Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg. The recall involves 8,681 unit cartons distributed nationwide. The specific lots affected are LF01643C and LF01644C, with an expiration date of 7/14.
The recall was initiated because inactive placebo tablets were incorrectly placed in Week 9, and active tablets were placed in Week 13 on the blister card. This sequencing error means the medication schedule on the packaging does not match the actual contents of the blister card.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only and was manufactured by Laboratorios Leon Farma S.A. in Spain for Sandoz Inc.
The recalled product
- 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
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Contraceptive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: LF01643C
- LF01644C
- Exp 7/14
Distribution
Distributed nationwide across the United States.
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