The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0958-2016·Announced 2016-06-15

Baxter Recalls Dextrose Injection Due to Insect Contamination

Baxter Healthcare is recalling Dextrose Injection, USP, 70% due to confirmed reports of an insect found in the primary container.

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 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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling Dextrose Injection, USP, 70%, 2000 mL VIAFLEX Plastic Container Bags. The recall involves 28,080 units of the product, which is a pharmacy bulk package intended for dilution and not for direct infusion. The affected lot is # C985150 with an expiration date of 07/16.

The recall was initiated due to confirmed customer complaints regarding the presence of particulate matter, specifically an insect found floating in the primary container of the product. The product was distributed nationwide.

Healthcare providers and pharmacies should stop using the affected product and contact Baxter Healthcare for further instructions. Consumers should not use the product if they have it in their possession.

The recalled product

Product
DEXTROSE (DEXTROSE MONOHYDRATE)
Brand
DEXTROSE
Affected units
28,080

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 # C985150
  • Exp. 07/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Similar recalls