Baxter Recalls 5% Dextrose Injection Bags Due to Metal Particulate Matter
Baxter Healthcare is recalling 402,284 bags of 5% Dextrose Injection due to the presence of metal particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Baxter Healthcare Corporation is recalling 402,284 bags of 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags. The recall is due to the presence of particulate matter, specifically metal, in the product.
The affected product is identified by Lot numbers C963413 and C963413A, with an expiration date of 7/31/2016. The product was distributed in the United States, Puerto Rico, and Bermuda. The product is an intravenous prescription drug manufactured by Baxter Healthcare Corporation.
Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Intravenous Solution
- Affected units
- 402,284
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 (2)
- Lot #: C963413 and C963413A
- Exp 7/31/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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