December 2014 FDA Recall Drug by Sandoz Incorporated
D-0291-2015 - Labeling

This Class III drug recall was voluntarily initiated by Sandoz Incorporated on December 5, 2014 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in AZ and the recall is currently terminated.

Recall Number: D-0291-2015

Reason for Recall
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Initiated
12-05-2014
Reported
12-17-2014
Quantity
1,008 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69942
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.
AZ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2015
Product Description About Product Description
Full technical description of the product.
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Batch or Lot Expiration Information

Lot# Lot ET5122, Exp. 10/17