PlainRecalls
FDA Drug Moderate Class II Terminated

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

Reported: May 17, 2017 Initiated: April 24, 2017 #D-0705-2017

Product Description

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

Reason for Recall

Microbial Contamination of Non-Sterile Products

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
N/A
Distribution
Nationwide
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel. Recalled by Teva Pharmaceuticals USA. Units affected: N/A.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products
Which agency issued this recall?
This recall was issued by the FDA Drug on May 17, 2017. Severity: Moderate. Recall number: D-0705-2017.