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

FDA recall notice · announced December 6, 2017 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Notes

Distribution: Nationwide
Lot/code information: Lot # 39C192, exp 06/2019
Quantity: 3,870 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0096-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.