The Recall Desk
ModerateFDA (Drugs)·D-0830-2016·Announced 2016-04-27

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.

What this means for you

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.
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.

See all 6 products in this recall →