Docusate Liquid Drug Recalled Over Incomplete Stability Testing
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, driven by the firm's inability to complete required stability studies due to closure, meeting the criterion for a voluntary precautionary recall.
Plain-English summary
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium, 50 mg/5 mL) in 473 mL bottles and 10 mL unit dose cups distributed nationwide in the USA and Puerto Rico.
The recall was initiated because the firm went out of business and can no longer conduct stability studies required under Current Good Manufacturing Practices (CGMP). These studies are essential to demonstrate that the drug maintains its safety and efficacy throughout its shelf life. Without completion of these studies, there is no confirmation that the product remains safe and effective.
This recall affects all lots of this product that were distributed nationwide in the United States and Puerto Rico.
Consumers should stop using this product and contact their healthcare provider or pharmacist for advice on obtaining an alternative stool softener.
The recalled product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Stool Softener / Laxative
- Hazard
- cgmp-violation
- stability-unverified
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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