April 2014 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1499-2014 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on April 1, 2014 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1499-2014

Reason for Recall
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Initiated
04-01-2014
Reported
08-06-2014
Quantity
89,215 blister pack

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67882
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
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.
11-20-2014
Product Description About Product Description
Full technical description of the product.
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78

Batch or Lot Expiration Information

Lot# 35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.