Adrucil — Class I drug recall D-1089-2015
Terminated recall by Teva Pharmaceuticals USA, reported 2015-07-15, distributed nationwide. Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces
| Recall number | D-1089-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2015-04-28 |
| Classified | 2015-07-07 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2016-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 6,195 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00703-3019-11 |
| Lot numbers | 31317858B, 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, 31318533B |
| Expiration dates | 2015-11, 2015-12, 2016-07 |
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 for recall
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1089-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.