Recalls / Class I
Class ID-1351-2015
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), 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).
- Affected lot / code info
- 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
Why it was recalled
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
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
- 6001 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-08-24
- Posted by FDA
- 2015-09-02
- Terminated
- 2016-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1351-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.