Drug recall D-1489-2019
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]
Reason for recall
Presence of Particulate Matter; glass particulates
Lots and codes
Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Melrose Park, IL
- Quantity
- 14,016 vials
- Distribution
- Nationwide USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 28, 2019
- Terminated
- September 20, 2022
Related products
- Fluorouracil – drug information
- NDC 63323-117 Fluorouracil · Fluorouracil 50 mg/mL · Fresenius Kabi USA, LLC