Fresenius Kabi Recalls Ondansetron Injection Due to Failed Impurity Specifications
Fresenius Kabi USA, LLC is recalling 11,981 vials of Ondansetron Injection, USP, 40 mg / 20 mL, because the product failed impurities and degradation specifications.
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 indicates that use of or exposure to the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification failures without reported harm.
Plain-English summary
Fresenius Kabi USA, LLC is voluntarily recalling 11,981 units of Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial. The product is identified by Lot # 6018699 and has an expiration date of 12/2021. The recall was initiated because the product failed impurities and degradation specifications.
The affected product is a prescription-only medication distributed nationwide within the United States. It is administered via intramuscular or intravenous routes. The NDC for the recalled product is 63323-374-20.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for further instructions. The 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.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON HYDROCHLORIDE)
- Brand
- ONDANSETRON
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 11,981
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 #: 6018699
- Exp. 12/2021
UPCs (2)
- 0363323374204
- 0363323373009
Distribution
Distributed nationwide across the United States.
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