Class II · Moderate risk
5-Fluorouracil 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Fluorouracil Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; glass particulates
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Affected NDCs
63323-0117-61
63323-0117-69
Compare with the code on your package — it is the most precise check available.
Drug: Fluorouracil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fluorouracil NDC 63323-0117 |
50 mg/mL | Injection, Solution Intravenous |
Fresenius Kabi USA, LLC | Rx |
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-117-69
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1489-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluorouracil recalls
See all
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class II · Moderate risk
Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML…
Lack of Assurance of Sterility
Class II · Moderate risk
Fluorouracil 560 MG / 11.2 ML IVP
Lack of Assurance of Sterility
Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other recalls by Fresenius Kabi USA, LLC
All 2019 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
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