Recall: D-1489-2019

Class I - Dangerous

Class IClassification

2019-06-28Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

Presence of Particulate Matter; glass particulates

Distribution

Nationwide USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.