Teva Recalls ADRUCIL Fluorouracil Injection Due to Particulate Matter
Teva Pharmaceuticals USA is recalling ADRUCIL (fluorouracil injection) vials due to the presence of silicone rubber and fluorouracil crystals in the solution.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,001 vials of ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL), manufactured by Teva Parenteral Medicines, Inc. The recall involves glass vials sold in cartons of five, with NDC numbers 073-3019-11 and 0703-3019-12. The affected lots are 31317857B, 31317859B, 31317920B, 31317957B, 31318136B, and 31318138B, with expiration dates ranging from August 2015 to December 2015.
The recall was initiated because particulate matter, specifically silicone rubber and fluorouracil crystals, was found floating in the solution. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected vials and contact Teva Pharmaceuticals USA for further instructions or to arrange for a return or replacement.
The recalled product
- 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).
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 6,001
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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