D-1370-2020 Class II Terminated
FDA drug recall D-1370-2020 was initiated by Aurobindo Pharma USA Inc. on June 12, 2020 and is designated Class II. Reason for recall: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. The recall status is terminated (terminated December 21, 2022). Affected quantity: 1440 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 12, 2020
- Termination Date
- December 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1440 bottles
Product Description
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
Reason for Recall
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: CZSC20003-A, Exp 1/2022