May 2012 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-1397-2012 - Impurities/Degradation

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on May 2, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1397-2012

Reason for Recall
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Initiated
05-02-2012
Reported
07-04-2012
Quantity
100,761 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61776
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.
Teva Pharmaceuticals USA, Inc.
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.
04-10-2013
Product Description About Product Description
Full technical description of the product.
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs

Batch or Lot Expiration Information

Lot# 's 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013