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Recall Observatory FDA recall evidence

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

July 24, 2015

Class I

Product summary

Firm
Teva Pharmaceuticals USA
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter