Fluorouracil Injection recall: Particulate Matter
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.…
Why was Fluorouracil Injection recalled?
Presence of Particulate Matter; glass particulates
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
- 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.…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 14,016 vials
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- July 24, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)