FDA-Drug2020-07-01Class II

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

Aurobindo Pharma USA Inc.
Hazard

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Sold states
U.S.A. Nationwide
Affected count
1440 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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

Official notice

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

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