FDA-Drug2013-07-24Class II
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
Sandoz Incorporated
Hazard
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Sold states
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Affected count
10,848 cartons
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-805-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief