Teva Recalls Adrucil Fluorouracil Injection Due to Particulate Matter
Teva Pharmaceuticals is recalling Adrucil (fluorouracil injection) vials due to the presence of black particulate matter, including silicone rubber and drug crystals.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,195 vials of Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package, 5 g/100 mL (50 mg/mL). The product is intended for intravenous use only and is distributed nationwide.
The recall was initiated because black particulate matter was identified in the product. This matter consists of an aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Healthcare providers and pharmacies should stop using the affected vials and follow Teva's instructions for return or destruction. Patients who have received the medication should contact their healthcare provider if they have concerns.
The recalled product
- Product
- 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
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Affected units
- 6,195
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 (11)
- Lot #s: 31317858B
- Exp 11/2015
- 31317899B
- 31317906B
- 31317958B
- 31317959B
- 31318103B
- 31318137B
- Exp 12/2015
- 31318533B
- Exp 07/2016
Distribution
Distributed nationwide across the United States.
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