AMINOSYN II 15% Amino Acid Injection Recalled for Particulate Matter
ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I. According to the severity rubric, FDA Class I recalls receive a minimum score of 4 (Severe), regardless of whether illnesses or injuries have been reported.
Plain-English summary
ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers (NDC 0409-7171-17, Lot 4989094, Expiration 01-APR-2022) because particulate matter has been identified in the product. The particulate matter consists of fibers, hair, proteinaceous material, and other particles.
This product was distributed nationwide in the USA. AMINOSYN II 15% is a prescription amino acid injection used in medical settings.
Consumers and healthcare providers who have received this product should not use it. Any remaining units of the affected lot should be quarantined and not administered to patients. Healthcare facilities should contact their supplier or ICU Medical Inc for instructions on returning the product or obtaining replacement units.
The recalled product
- Product
- AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
- Manufacturer
- ICU Medical Inc
- Affected units
- 2,112
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 (1)
- Lot: 4989094 Exp. 01-APR-2022
Distribution
Distributed nationwide across the United States.
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