Hospira Recalls Aminosyn-PF Amino Acid Bags Due to Chemical Contamination
Hospira Inc. is recalling 1,776 bags of Aminosyn-PF (amino acids) 7% 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a 'potential' contamination without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Hospira Inc. is recalling 1,776 bags of Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags. The recall is due to a potential chemical contamination involving an aromatic hydrocarbon resin.
The affected product is identified by Lot # 49-047-JT with an expiration date of 07/16. The NDC is 0409-4178-03. The product was distributed nationwide in the United States and in Singapore.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 1,776
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# 49-047-JT
- Exp: 07/16
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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