Recalls / Class I
Class ID-1089-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016
Why it was recalled
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 6195 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-28
- FDA classified
- 2015-07-07
- Posted by FDA
- 2015-07-15
- Terminated
- 2016-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1089-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.