Why it was recalled
Presence of Particulate Matter; glass particulates
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]
Lot numbers, UPCs & expiration codes
Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1489-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 28, 2019
- FDA report date
- Jul 24, 2019
- Quantity
- 14,016 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1489-2019, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83234
- Address
- 2045 Cornell Ave
- Code information
- Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
- Postal code
- 60160-1002
- Report date
- Jul 24, 2019
- Product type
- Drugs
- Recall number
- D-1489-2019
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 14,016 vials
- Termination date
- Sep 20, 2022
- Reason for recall
- Presence of Particulate Matter; glass particulates
- Voluntary / mandated
- Voluntary: Firm initiated
- 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]
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Jun 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2019