Hospira Recalls Aminosyn II Amino Acid Injection Due to Particulate Matter
Hospira is recalling 17,256 containers of Aminosyn II 10% Amino Acid Injection because a human hair was found in the injection port.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 17,256 containers of Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL. The recall involves Lot 26-138-JT with an expiration date of 08/14. The product was distributed nationwide.
The recall was initiated due to a confirmed customer complaint identifying particulate matter, specifically a human hair, visible in the injection port and primary container. This is an FDA Class I recall.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above.
The recalled product
- Product
- Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 17,256
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# 26-138-JT
- Exp. 08/14
Distribution
Distributed nationwide across the United States.
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