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Class II: temporary or reversible health riskTerminated

Akorn Levetiracetam Oral Solution Recall

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHAR…

Akorn, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jan 20, 2021
Recall ID
D-0221-2021
Check your lot numberHow we source this data

Summary

Akorn recalled Levetiracetam Oral Solution starting Dec 28, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0221-2021 on Jan 20, 2021. Reason: Defective container: Customer complaints for oral solution leaking from bottles. Status: Terminated.

Why it was recalled

Defective container: Customer complaints for oral solution leaking from bottles.

Product description

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

Lot numbers, UPCs & expiration codes

Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022

Where it was sold

Nationwide in the USA and Puerto Rico

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-0221-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 28, 2020
FDA report date
Jan 20, 2021
Quantity
22,248 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0221-2021, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
87051
Address
1925 W Field Ct Ste 300
Code information
Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
Postal code
60045-4862
Report date
Jan 20, 2021
Product type
Drugs
Recall number
D-0221-2021
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
22,248 bottles
Termination date
Aug 9, 2022
Reason for recall
Defective container: Customer complaints for oral solution leaking from bottles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
Distribution pattern
Nationwide in the USA and Puerto Rico
Recall initiation date
Dec 28, 2020
Initial firm notification
Letter
Center classification date
Jan 11, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0221-2021, published Jan 20, 2021. 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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