Recalls / Class II
Class IID-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
- Brand name
- Clozapine
- Generic name
- Clozapine
- Active ingredient
- Clozapine
- Route
- Oral
- NDCs
- 65862-844, 65862-845, 65862-846, 65862-847
- FDA application
- ANDA206433
- Affected lot / code info
- Lot #: CZSC20003-A, Exp 1/2022
Why it was recalled
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 1440 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-06-12
- FDA classified
- 2020-06-30
- Posted by FDA
- 2020-07-01
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1370-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.