FDA Drug recall D-1351-2015
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medi…
- FDA Drug
- Class I
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class I recall of ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medi… by Teva Pharmaceuticals Usa, citing presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1351-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-07-24 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
Reason
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Identifiers
| code_info | Lot # 31317857B, Exp 08/15 31317859B, Exp 12/15 31317920B, Exp 12/15 31317957B, Exp 12/15 31318136B, Exp 12/15 31318138B, Exp 12/15 |
|---|
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-1351-2015%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.