Reported Jul 24, 2019 · Terminated
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 2045 Cornell Ave · Melrose Park, IL · 60160-1002
Is this the product you have?
- Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd
- byFresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
- Lot codes and dates
- Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
- Amount recalled
- 14,016 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter; glass particulates
Using this product could cause serious injury, illness or death — stop using it now.
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