PlainRecalls
FDA Drug Moderate Class II Ongoing

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Reported: June 7, 2023 Initiated: April 26, 2023 #D-0816-2023

Product Description

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Reason for Recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Details

Recalling Firm
Akorn, Inc.
Units Affected
N/A
Distribution
Nationwide in the USA and Puerto Rico
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs. Recalled by Akorn, Inc.. Units affected: N/A.
Why was this product recalled?
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0816-2023.