January 2013 FDA Recall Drug by Sandoz Incorporated
D-152-2013 - Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

This Class III drug recall was voluntarily initiated by Sandoz Incorporated on January 22, 2013 for the product Drug. The FDA reported the reason for recall as tablet/capsule imprinted with wrong id; a portion of the tablets could contain the incorrect debossing on one side of the tablet u2 instead of u3.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-152-2013

Reason for Recall
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Initiated
01-22-2013
Reported
02-13-2013
Quantity
17,188 cartons containing 3 cards each.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64118
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2013
Product Description About Product Description
Full technical description of the product.
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

Batch or Lot Expiration Information

Lot# LF01215A, Exp 02/2014