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Class I: serious health riskTerminated

Lannett Levetiracetam Oral Solution 100mg/mL Recall

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl

Lannett Company, Inc. · Philadelphia, PA

Risk level
Class I
Reported by FDA
Dec 25, 2019
Recall ID
D-0630-2020
Check your lot numberHow we source this data

Summary

Lannett recalled Levetiracetam Oral Solution 100mg/mL starting Dec 6, 2019. The FDA classified it as Class I (serious health risk) and published enforcement report D-0630-2020 on Dec 25, 2019. Reason: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0630-2020
Classification
Class I
Status
Terminated
Recall initiated
Dec 6, 2019
FDA report date
Dec 25, 2019
Quantity
16,668 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lannett Company, Inc.

Original FDA data

Every field from FDA enforcement report D-0630-2020, exactly as published.

Show all FDA fields
City
Philadelphia
State
PA
Status
Terminated
Country
United States
Event ID
84427
Address
9000 State Rd
Code information
Lot #: 2190A, 2191A, Exp. Date 07/2021
Postal code
19136-1615
Report date
Dec 25, 2019
Product type
Drugs
Recall number
D-0630-2020
Classification
Class I
Recalling firm
Lannett Company, Inc.
Product quantity
16,668 bottles
Termination date
Jul 13, 2020
Reason for recall
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide within the United States
Recall initiation date
Dec 6, 2019
Initial firm notification
Letter
Center classification date
Dec 27, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0630-2020, published Dec 25, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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