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
Reported: July 1, 2020 Initiated: June 12, 2020 #D-1370-2020
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.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 1440 bottles
- Distribution
- U.S.A. Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 1440 bottles.
Why was this product recalled? ▼
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 1, 2020. Severity: Moderate. Recall number: D-1370-2020.
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