FDAClass IIJune 7, 2023

Docu Liquid recall: CGMP Deviations

DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Why was Docu Liquid recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

All Lots

Product
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Recalling firm
Akorn, Inc.
Quantity
N/A
Distribution
Nationwide in the USA and Puerto Rico
Recall date
June 7, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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