The Recall Desk
SevereFDA (Drugs)·D-0426-2015·Announced 2015-04-01

Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

Baxter Healthcare is recalling 48,874 units of 5% Dextrose Injection because missing closures or leaks may compromise sterility.

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 recall is classified as FDA Class II and involves a potential sterility failure in an intravenous product, which poses a significant risk of serious injury or infection.

Plain-English summary

Baxter Healthcare Corp. is recalling 48,874 units of 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container. The product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corp. in Marion, North Carolina, and distributed nationwide. The specific lot affected is C926899, with an expiration date of 7/31/2015.

The recall was initiated due to a lack of assurance of sterility. Complaints were received regarding missing closures and/or leaks in the product containers, which may compromise the sterility of the solution. This is classified as an FDA Class II recall.

Healthcare providers and patients should stop using the affected lot of 5% Dextrose Injection. Consumers should check their inventory for the specific lot number C926899 and expiration date 7/31/2015. If the product matches these details, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
DEXTROSE (DEXTROSE MONOHYDRATE)
Brand
DEXTROSE
Affected units
48,874

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 #: C926899
  • Exp 7/31/2015

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 →