Drug 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).
D-1351-2015
Product summary
- Event
- Event 71799
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6001 vials
- Official record key
drug-enforcement:D-1351-2015
Official wording
Reason: Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Code information: 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
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter