FDA recall D-1370-2020

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

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

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-06-12

Report date

2020-07-01

Termination date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1370-2020