Fresenius Kabi Recalls KABIVEN IV Bags Due to Amino Acid Labeling Error
Fresenius Kabi is recalling 5,488 bags of KABIVEN IV solution because the label lists 3.1% amino acids, but the product actually contains 3.3%.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II and involves a minor labeling error regarding the concentration of an ingredient, with no reported illnesses or injuries in the source text.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 5,488 bags of KABIVEN (Dextrose, Soybean Oil, Electrolytes, and Amino Acids) Injectable Emulsion. The recall was initiated due to a labeling error regarding the declared strength of the amino acids. The product is labeled as containing 3.1% amino acids, but it actually contains 3.3% amino acids.
The affected product is a prescription-only intravenous solution manufactured by Fresenius Kabi Uppsala, Sweden, and packaged in 1,540 mL and 2,053 mL bags. The specific lots involved are #10HH8781 and #10HH8739, both with an expiration date of 07-2016. The product was distributed nationwide in the United States, including Puerto Rico.
This recall is classified as FDA Class II. Healthcare providers and patients should check their inventory for the specific lot numbers and NDC codes listed in the recall notice. If the product has been administered, no specific adverse health consequences are reported in the source text, but the discrepancy in amino acid concentration should be noted for clinical records.
The recalled product
- Product
- KABIVEN (DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
- Brand
- KABIVEN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Intravenous Solution
- Hazard
- Affected units
- 5,488
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 (4)
- 1) Lot # 10HH8781
- Expiry: 07-2016
- 2) Lot # 10HH8739
- Expiry: 07-2016.
UPCs (4)
- 0363323712105
- 0363323712204
- 0363323712150
- 0363323712259
Distribution
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