Hospira Recalls Mannitol I.V. Bags Due to Chemical Contamination Risk
Hospira Inc. is recalling 22,292 bags of Mannitol I.V. 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalization reports or fatalities are mentioned in the source text.
Plain-English summary
Hospira Inc. is recalling 22,292 bags of Mannitol I.V., 20%, USP (20 g/100 mL), packaged in 250 mL bags. The product is identified by NDC 0409-7715-02, Lot# 52-031-JT, and an expiration date of 10/16.
The recall was initiated due to a potential for contamination of the products with an aromatic hydrocarbon resin. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide in the United States and in Singapore. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 22,292
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# 52-031-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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