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 Indust

FDA recall notice · announced May 17, 2017 · Teva Pharmaceuticals

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

The product

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

Notes

Distribution: Nationwide
Lot/code information: 100 (NDC 0093-4359-01) and 500 count bottles (NDC 0093-4359-05)- Lot # 07C160; Exp. 03/18 100 Unit Dose Blisters/Carton (NDC 0093-4359-93) and Individual Blister Pack (NDC 0093-4359-19) - Lot # 07C160A; Exp. 03/18
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 (D-0705-2017)

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