Lactulose Solution Recall Due to Manufacturing Practice Deviations
Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall due to manufacturing practice deviations. While no illnesses or adverse events have been reported, the classification reflects the potential risk from inability to verify the product's ongoing safety and effectiveness due to incomplete stability studies.
Plain-English summary
Akorn, Inc. of Gurnee, Illinois has recalled all lots of Lactulose Solution, USP for oral or rectal administration distributed nationwide in the United States and Puerto Rico. The recall affects 30 mL unit dose cups.
The FDA Class II recall was issued due to current good manufacturing practice (CGMP) deviations. Specifically, the firm ceased business operations and was therefore unable to continue required stability studies on the product.
Stability studies are required to ensure that medications maintain their safety and effectiveness throughout their shelf life. The inability to complete these studies means the safety and efficacy of the product cannot be verified.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should stop dispensing this product and quarantine remaining inventory.
The recalled product
- Product
- Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — CGMP Violation
- Hazard
- manufacturing-deviation
- unverified-stability
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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