FDA Drug recall D-1089-2015
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx On…
- FDA Drug
- Class I
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class I recall of Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx On… by Teva Pharmaceuticals Usa, citing presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1089-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-04-28 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
Reason
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Identifiers
| code_info | Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1089-2015%22
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