Recall: D-1233-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-18Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

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

Reason

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.