Product Detail

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

Recall Number D-805-2013

Classification Class II

Code Info Lot: LF01213A, Exp. 02/14

Product Distributed Qty 10,848 cartons

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

Event Detail

Event Id 65511

Product Type Drugs

Status Ongoing

Recalling Firm

Sandoz Incorporated
City Broomfield

State CO
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-21

Initial Firm Notification of Consignee or Public Letter

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