Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter
Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.
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: This recall is classified by the FDA as Class I, which by the rubric criteria requires a minimum score of 4. Particulate matter in an intravenous injection represents a significant risk of harm to patients, as such injections are administered directly into the bloodstream.
Plain-English summary
Fresenius Kabi USA, LLC is recalling Sodium Acetate Injection, USP (4 mEq/mL, 100 mL vials) because the product contains particulate matter. The particulates are composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum, and cellulose.
The affected lots are: 6124193, 6124196, 6124226 (expiration 05/2022); 6124532 (expiration 06/2022); 6125333 (expiration 12/2022); 6125678 (expiration 01/2023); and 6126846 (expiration 08/2023). A total of 118,040 vials were distributed nationwide.
Sodium acetate injection is administered intravenously and is a prescription-only drug. The presence of particulate matter in intravenous medications poses a risk to patients. Healthcare providers and patients who have received this product should consult with a healthcare professional. The product should not be used.
The recalled product
- Product
- SODIUM ACETATE (SODIUM ACETATE)
- Brand
- SODIUM ACETATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Intravenous Injection
- Affected units
- 118,040
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 (12)
- Lot #: 6124193
- 6124196
- 6124226
- Exp 05/2022
- 6124532
- Exp 06/2022
- 6125333
- Exp 12/2022
- 6125678
- Exp 01/2023
- 6126846
- Exp 08/2023
Distribution
Distributed nationwide across the United States.
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