Class I
Terminated
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).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- July 24, 2015
- Posted
- September 2, 2015
- Recall Number
- D-1351-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6001 vials
- Firm Location
- Horsham, PA, United States
Reason for Recall
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Distribution
Nationwide.
Lot / Code Info
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
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