FDAFDA · Food and drugs·Recall number D-805-2013
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Published July 24, 2013 · Recall initiated: June 21, 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: A placebo tablet was found in a row of active tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Incorporated
- Distributor
- Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
- Lot
- Lot: LF01213A, Exp. 02/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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