FDAClass IIApril 22, 2020

Levetiracetam Tablets USP 750 mg 120-count bottles recall: CGMP Deviations

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

Why was Levetiracetam Tablets USP 750 mg 120-count bottles recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 24719001A1, Exp. Date 03/2021

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
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
8040 units
Distribution
Nationwide within the United States
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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