ADRUCIL — Class I drug recall D-1351-2015
Terminated recall by Teva Pharmaceuticals USA, reported 2015-09-02, distributed nationwide. Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
| Recall number | D-1351-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2015-07-24 |
| Classified | 2015-08-24 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,001 vials |
| Reason classes | specification failure |
| NDC | 00703-3019-12 |
| Lot numbers | 08/15, 12/15, 31317857B, 31317859B, 31317920B, 31317957B, 31318136B, 31318138B |
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 for recall
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
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-1351-2015. 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.