June 2020 FDA Recall Drug by Aurobindo Pharma Usa Inc.
D-1370-2020 - Presence of foreign tablet
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on June 12, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1370-2020
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
06-12-2020
07-01-2020
1440 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
12-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : CZSC20003-A, Exp 1/2022
