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FDAFDA · Food and drugs·Recall number D-1370-2020

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

Published July 1, 2020 · Recall initiated: June 12, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CLOZAPINE
Manufacturer
Aurobindo Pharma USA Inc.
Distributor
U.S.A. Nationwide
UPC
0365862844019
Lot
Lot #: CZSC20003-A, Exp 1/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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