FDA Recall D-1089-2015

Teva Pharmaceuticals USA · Horsham, PA

Class I — life-threatening Terminated 556 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016

Quantity: 6195 vials

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.

Recall record

Recall number: D-1089-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2015-04-28
Classified by FDA Center: 2015-07-07
FDA published: 2015-07-15
Terminated: 2016-11-04
Recalling firm: Teva Pharmaceuticals USA
Firm location: Horsham, PA

‹ All recalls