D-805-2013 Class II Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
July 24, 2013
Initiation Date
June 21, 2013
Termination Date
January 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,848 cartons

Product Description

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 Pattern

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

Code Information

Lot: LF01213A, Exp. 02/14