Recall record at a glance
| Official record | D-1690-2012 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Baxter Healthcare Corp. |
| Report date | Oct 3, 2012 |
| Recall initiation date | Sep 21, 2012 |
| Quantity | 55,664 containers |
| Location | Round Lake, IL, United States |
Official 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
Why the product was recalled
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Distribution information
Nationwide and Puerto Rico
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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