Reported Jun 10, 2015 · Terminated
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free],…
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only
- Manufactured by
FRESENIUS KABI UppsalaSweden. Packaged in 1) 1540 mL Bags
- NDC
63323-712-15and 2) 2053 mL Bags
- NDC63323-712-20
- Lot codes and dates
- 1) Lot # 10HH8781
- Expiry
07-20162) Lot # 10HH8739
- Expiry07-2016
- Amount recalled
- 5,488 Bags
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
This product could cause temporary or reversible health problems — stop using it.
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