Drug product
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
D-1370-2020
Product summary
- Event
- Event 85852
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1440 bottles
- Official record key
drug-enforcement:D-1370-2020
Official wording
Reason: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Code information: Lot #: CZSC20003-A, Exp 1/2022
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet