Fresenius Kabi Recalls Fluorouracil Injection Due to Glass Particulates
Fresenius Kabi USA, LLC is recalling 14,016 vials of Fluorouracil Injection due to the presence of glass particulates.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Fresenius Kabi USA, LLC is voluntarily recalling 14,016 vials of Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL). The product is a prescription-only intravenous medication manufactured by Fresenius Kabi in Lake Zurich, IL. The recall is being conducted because of the presence of particulate matter, specifically glass particulates, in the vials.
The affected products include Lot 6120420 (NDC 63323-117-61, Product Code 101761) and Lot 6120341 (NDC 63323-117-69, Product Code NP101761). These vials were distributed nationwide in the United States and Puerto Rico. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- FLUOROURACIL (FLUOROURACIL)
- Brand
- FLUOROURACIL
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Affected units
- 14,016
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 (3)
- Lot 6120420 NDC 63323-117-61
- Product Code 101761 and Lot 6120341 NDC 63323-117-69
- Product Code NP101761
UPCs (4)
- 0363323117610
- 0363323117511
- 0363323117696
- 0363323117597
Distribution
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