Recalls / Class II
Class IID-1688-2012
Product
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
- Affected lot / code info
- Lot #: C828814, Exp 12/12; C841551, Exp 04/13
Why it was recalled
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Route 120 And Wilson Rd, N/A, Round Lake, Illinois 60073-9799
Distribution
- Quantity
- 5,064 containers
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-09-21
- FDA classified
- 2012-09-25
- Posted by FDA
- 2012-10-03
- Terminated
- 2015-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1688-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.