Sandoz Incorporated recalls Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufac
Recalled July 24, 2013 · FDA recall D-805-2013 · Sandoz Incorporated
Hazard
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. · FDA Class II
Units
10,848 cartons
Sold at
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Description
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Product
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
Manufacturer(s)
Sandoz Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →