The Recall Desk
SevereFDA (Drugs)·D-1162-2014·Announced 2014-03-26

Baxter Recalls 5% Dextrose Injection Due to Particulate Matter

Baxter Healthcare is voluntarily recalling 105,216 containers of 5% Dextrose Injection due to the presence of particulate matter, including fibers and plastic particles.

What this means for you

Illness, injury, or structural failure has been reported. 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 issuing a voluntary recall of 5% Dextrose Injection, USP, 100 mL single-dose VIAFLEX plastic containers. The recall involves 105,216 containers from Lot P285288, which has an expiration date of 11/13. The product is distributed nationwide, as well as in Puerto Rico, Singapore, Saudi Arabia, and the United Arab Emirates.

The recall is being conducted due to the presence of particulate matter in the solution. The identified particles include polyester and cotton fibers, an adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene, and human hair embedded in the plastic bag.

Healthcare providers and patients should stop using the affected product. Baxter Healthcare is the recalling firm responsible for this action.

The recalled product

Product
DEXTROSE (DEXTROSE MONOHYDRATE)
Brand
DEXTROSE
Affected units
105,216

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 #: P285288
  • Exp 11/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →