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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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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