The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0815-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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