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.
- Category
- Drug — Injectable Solution
- Hazard
- 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.
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