The Recall Desk
HighFDA (Drugs)·D-0826-2023·Announced 2023-06-07

Lorazepam Oral Concentrate Recalled Due to Manufacturing Practice Deviations

Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.

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: FDA Class II recall for risk-of-harm product: medication with unverified stability due to CGMP deviations and inability to complete shelf-life studies. Warrants High severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate, USP, 2 mg per mL in 30 mL bottles. The product was distributed nationwide in the United States and Puerto Rico.

The recall stems from Current Good Manufacturing Practice (CGMP) deviations. Akorn went out of business and was unable to complete stability studies required to verify the product remains safe and effective over its shelf life.

The recalled product

Product
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Benzodiazepine
Hazard
  • cgmp-deviation
  • 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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