Recalls / Class II
Class IID-1233-2020
Product
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
- Brand name
- Levetiracetam
- Generic name
- Levetiracetam
- Active ingredient
- Levetiracetam
- Route
- Oral
- NDCs
- 65862-245, 65862-246, 65862-247, 65862-315
- FDA application
- ANDA078993
- Affected lot / code info
- Lot #: 24719001A1, Exp. Date 03/2021
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 8040 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-18
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1233-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.