The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0829-2016·Announced 2016-04-27

Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination Risk

Hospira Inc. is recalling 552 bags of Dextrose Injection, USP, 20% due to potential contamination with an aromatic hydrocarbon resin.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential chemical contamination in injectable products.

Plain-English summary

Hospira Inc. is voluntarily recalling 552 bags of Dextrose Injection, USP, 20%, packaged as 500 mL in 1000 mL bags. The product is identified by NDC 0409-7935-19, Lot# 52-114-JT, and an expiration date of 10/16.

The recall was initiated because of a potential for contamination of the products with an aromatic hydrocarbon resin. The agency has classified this recall as Class II.

The affected product was distributed nationwide in the United States and in Singapore. Healthcare facilities and pharmacies should stop using the product and contact Hospira Inc. for further instructions.

The recalled product

Product
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Manufacturer
Hospira Inc.
Affected units
552

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# 52-114-JT
  • Exp 10/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Hospira Inc. 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 6 products in this recall →

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