June 2013 FDA Recall Drug by Sandoz Incorporated
D-805-2013 - Contraceptive Tablets out of Sequence

This Class II drug recall was voluntarily initiated by Sandoz Incorporated on June 21, 2013 for the product Drug. The FDA reported the reason for recall as contraceptive tablets out of sequence. The product was distributed in Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees. and the recall is currently terminated.

Recall Number: D-805-2013

Reason for Recall
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Initiated
06-21-2013
Reported
07-24-2013
Quantity
10,848 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65511
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2014
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: LF01213A, Exp. 02/14