Baxter Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Chemical Contamination
Baxter Healthcare is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP due to potential trace levels of cumene hydroperoxide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization are rated as Severe (4).
Plain-English summary
Baxter Healthcare Corporation is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in 500 mL AVIVA containers. The product is prescription-only and was distributed nationwide and in Puerto Rico.
The recall was initiated because the IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). This is a chemical contamination issue.
Affected lots include C828814 (expiration 12/12) and C841551 (expiration 04/13). Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare for further instructions.
The recalled product
- 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
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solutions
- Hazard
- Affected units
- 5,064
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: C828814
- Exp 12/12
- C841551
- Exp 04/13
Distribution
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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