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.
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: 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
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
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.
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