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]
Reported: July 24, 2019 Initiated: June 28, 2019 #D-1489-2019
Product Description
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
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 14,016 vials
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
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]. Recalled by Fresenius Kabi USA, LLC. Units affected: 14,016 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; glass particulates
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2019. Severity: Critical. Recall number: D-1489-2019.
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