Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 4,368 bags of Dextrose Injection, USP, 50% 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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.
Plain-English summary
Hospira Inc. is recalling 4,368 bags of Dextrose Injection, USP, 50%, packaged as 500 mL in 1000 mL bags. The product is identified by NDC 0409-7936-19 and Lot # 52-002-JT, with an expiration date of 04/17.
The recall was initiated because of a potential for contamination of the products with an aromatic hydrocarbon resin. The affected units were distributed nationwide in the United States and in Singapore.
Healthcare providers and patients should stop using the affected product and contact Hospira Inc. for further instructions or a replacement.
The recalled product
- Product
- Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4,368
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 # 52-002-JT
- Exp 04/17
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 →Related recalls
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