February 2018 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0578-2018 - Failed impurities/ degradation specifications

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on February 5, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/ degradation specifications. The product was distributed in Distributed throughout the United States and the recall is currently terminated.

Recall Number: D-0578-2018

Reason for Recall
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Initiated
02-05-2018
Reported
02-21-2018
Quantity
1,157,095 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79118
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.
Teva Pharmaceuticals USA
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 throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2019
Product Description About Product Description
Full technical description of the product.
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

Batch or Lot Expiration Information

Lot# All lots within expiry.