Recalls / Class I
Class ID-1489-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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]
- Brand name
- Fluorouracil
- Generic name
- Fluorouracil
- Active ingredient
- Fluorouracil
- Route
- Intravenous
- NDC
- 63323-117
- FDA application
- ANDA040278
- Affected lot / code info
- Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Why it was recalled
Presence of Particulate Matter; glass particulates
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2045 Cornell Ave, N/A, Melrose Park, Illinois 60160-1002
Distribution
- Quantity
- 14,016 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-06-28
- FDA classified
- 2019-07-17
- Posted by FDA
- 2019-07-24
- Terminated
- 2022-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1489-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.