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
Reported: December 6, 2017 Initiated: November 9, 2017 #D-0096-2018
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 3,870 bottles
- Distribution
- Nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 3,870 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 6, 2017. Severity: Moderate. Recall number: D-0096-2018.
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