Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMA...
FDA Recall #D-0096-2018 — Class II — November 9, 2017
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,870 bottles
Distribution
Nationwide
Code Information
Lot # 39C192, exp 06/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated