Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | D-1688-2012 |
| Classification | Class II |
| Code Info | Lot #: C828814, Exp 12/12; C841551, Exp 04/13 |
| Product Distributed Qty | 5,064 containers |
| Reason For Recall | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). |
Event Detail
| Event Id | 63189 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Baxter Healthcare Corp. |
| City | Round Lake |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
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