Class I
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- April 28, 2015
- Posted
- July 15, 2015
- Recall Number
- D-1089-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6195 vials
- Firm Location
- Horsham, PA, United States
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.
Distribution
Nationwide
Lot / Code Info
Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016
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