The Recall Desk
HighFDA (Drugs)·D-0825-2023·Announced 2023-06-07

Lorazepam Injection Recalled Due to Manufacturing Control Deviations

Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue 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: This is a Class II FDA recall for CGMP deviations affecting a parenteral benzodiazepine due to incomplete stability testing. No illnesses or injuries have been reported, making this a theoretical risk-of-harm product situation, which meets the High severity criterion.

Plain-English summary

Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL in 1 mL vials, manufactured by Akorn, Inc. in Lake Forest, Illinois. The product was distributed nationwide in the USA and Puerto Rico. This is a Class II recall.

The recall has been issued due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm went out of business and was unable to continue the stability studies required to verify and maintain the product's integrity and safety throughout its shelf life.

The recalled product

Product
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable Benzodiazepine
Hazard
  • cgmp-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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