FDAClass IDecember 25, 2019

Levetiracetam Oral Solution 100mg/mL recall: Sterility Concern

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Why was Levetiracetam Oral Solution 100mg/mL recalled?

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

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 #: 2190A, 2191A, Exp. Date 07/2021

Product
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Recalling firm
Lannett Company, Inc.
Quantity
16,668 bottles
Distribution
Nationwide within the United States
Recall date
December 25, 2019
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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