The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0798-2023·Announced 2023-06-07

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.

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 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

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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