PlainRecalls
FDA Drug Moderate Class II Ongoing

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Reported: June 7, 2023 Initiated: April 26, 2023 #D-0815-2023

Product Description

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, 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?
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, 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-0815-2023.