Status
Terminated
Drug Enforcement D-1690-2012
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Classification
Class II
Report Date
October 3, 2012
Termination Date
May 4, 2015
Product Information
- Product description
- 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
- Product quantity
- 55,664 containers
- Reason for recall
- Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
Route 120 And Wilson Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1690-2012
- Event ID
- 63189
- Recall initiation date
- September 21, 2012
- Center classification date
- September 25, 2012
- 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
- More code info
- —