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.
What this means for you
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
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