Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity Failure
Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials 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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Fresenius Kabi USA LLC is recalling 216,517 vials of Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial. The recall was initiated due to an out-of-specification result regarding impurities or degradation specifications.
The affected product is a prescription-only intramuscular injection manufactured by Fresenius Kabi USA LLC in Schaumburg, IL. The recall covers specific lots with expiration dates ranging from May 2014 to February 2015. The product was distributed nationwide and in Puerto Rico.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected lots and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Fresenius Kabi USA LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 216,517
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 (10)
- Lot 6105149
- Exp.05/14
- 6105696
- Exp. 07/14
- 6105836
- Exp. 08/14
- Lot 6106516
- Exp. 12/14
- Lot 6106837
- Exp. 02/15
Distribution
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