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).
Reported: September 2, 2015 Initiated: July 24, 2015 #D-1351-2015
Product Description
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).
Reason for Recall
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 6001 vials
- Distribution
- Nationwide.
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Teva Pharmaceuticals USA. Units affected: 6001 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2015. Severity: Critical. Recall number: D-1351-2015.
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