Drug 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]
D-1489-2019
Product summary
- Event
- Event 83234
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,016 vials
- Official record key
drug-enforcement:D-1489-2019
Official wording
Reason: Presence of Particulate Matter; glass particulates
Code information: Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter