Levetiracetam Tablets USP 750 mg bottles recalled over manufacturing violations

Recall date

March 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aurobindo Pharma USA Inc. recalls Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-H…

Recall number

D-1233-2020

FDA classification

Class II

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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