November 2017 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0096-2018 - Failed Tablet/Capsule Specifications; potential presence of broken tablets.

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 9, 2017 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications; potential presence of broken tablets.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0096-2018

Reason for Recall
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Initiated
11-09-2017
Reported
12-06-2017
Quantity
3,870 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78552
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.
07-03-2018
Product Description About Product Description
Full technical description of the product.
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05

Batch or Lot Expiration Information

Lot# 39C192, exp 06/2019