FDA Recalls DetomiSed Drug Due to Incomplete Stability Testing
FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct 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 an FDA Class II drug recall with no reported illnesses or injuries. The hazard is theoretical—inability to verify product stability through continued testing—which qualifies as a risk-of-harm scenario without yet-reported harm. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
The FDA is recalling all lots of DetomiSed (detomidine hydrochloride) in 5mL and 20mL vials, a prescription-only drug manufactured by Akorn, Inc. and distributed by Akorn Operating Company, LLC in Gurnee, Illinois. The recall was initiated due to CGMP deviations: Akorn, Inc. ceased business operations and could no longer continue stability studies.
The product was distributed nationwide throughout the United States and Puerto Rico. All lots of the product are included in this recall.
Individuals and facilities with DetomiSed should be aware of this recall. For further information regarding the recall or guidance on handling existing inventory, contact Akorn, Inc. or the FDA.
The recalled product
- Product
- DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
- incomplete-stability-studies
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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