FDA Recall D-1351-2015

Teva Pharmaceuticals USA · Horsham, PA

Class I — life-threatening Terminated 467 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), 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).

Lot / code: 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

Quantity: 6001 vials

Reason for recall

Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

Recall record

Recall number: D-1351-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide.
Recall initiated: 2015-07-24
Classified by FDA Center: 2015-08-24
FDA published: 2015-09-02
Terminated: 2016-11-02
Recalling firm: Teva Pharmaceuticals USA
Firm location: Horsham, PA

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