FDA recall D-805-2013

Sandoz Incorporated · Class II · drug

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

Reason for recall

Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

Distribution

Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.

Key facts

Status: Terminated
Initiation date: 2013-06-21
Report date: 2013-07-24
Termination date: 2014-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-805-2013