FDA Drug recall D-1489-2019
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 600…
- FDA Drug
- Class I
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class I recall of 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 600… by Fresenius Kabi Usa, citing presence of Particulate Matter; glass particulates.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1489-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-06-28 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Identifiers
| ndc | 63323-117-51 |
|---|---|
| ndc | 63323-117-61 |
| ndc | 63323-117-59 |
| ndc | 63323-117-69 |
| code_info | Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1489-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.