Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities
Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which the rubric defines as unlikely to cause adverse health consequences. The issue involves out-of-specification degradation products without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL). The product is distributed in 20 mL glass Abboject syringes with male luer lock adapters and is available by prescription only. The specific lot affected is 34-531-DK, with an expiration date of 10/01/2015.
The recall was initiated because out-of-specification (OOS) results for a degradation product of etomidate were confirmed during stability testing. This indicates that the impurities or degradation levels in the medication exceeded the established specifications.
The affected product was distributed nationwide. Healthcare providers and patients should discontinue use of the recalled lot and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 24,100
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 34-531-DK
- Exp 10/01/2015
Distribution
Distributed nationwide across the United States.
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