Drug 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
D-0705-2017
Product summary
- Event
- Event 77109
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0705-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products
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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination