The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0818-2016·Announced 2016-04-20

Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity

Fresenius Kabi USA, LLC is recalling Haloperidol Decanoate Injection due to an impurity out-of-specification result. The recall affects 48,210 units distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Fresenius Kabi USA, LLC is recalling Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. The recall is due to an impurity out-of-specification result. The affected product is identified by Lot # 6111080 with an expiration date of 01/2017.

The recall involves 48,210 units of the medication. The product was distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. Consumers should not attempt to use the medication if they have questions about its safety or efficacy.

The recalled product

Product
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand
HALOPERIDOL DECANOATE
Manufacturer
Fresenius Kabi USA, LLC
Category
Drug — Antipsychotic
Hazard
Affected units
48,210

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 (2)

  • Lot #: 6111080
  • Exp. 01/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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