Recalls / Class II
Class IID-1690-2012
Product
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Affected lot / code info
- Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13
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
- 55,664 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-1690-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.