Recalls / Class II
Class IID-1114-2015
Product
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 Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.
- Brand name
- Kabiven
- Generic name
- Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
- Active ingredients
- Alanine, Arginine, Aspartic Acid, Calcium Chloride, Dextrose Monohydrate, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine Hydrochloride, Magnesium Sulfate Heptahydrate, Methionine, Phenylalanine, Potassium Chloride, Proline, Serine, Sodium Acetate, Sodium Glycerophosphate Anhydrous, Soybean Oil, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDC
- 63323-712
- FDA application
- NDA200656
- Affected lot / code info
- 1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
Why it was recalled
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 5,488 Bags
- Distribution pattern
- US; Nationwide, including Puerto Rico
Timeline
- Recall initiated
- 2015-04-28
- FDA classified
- 2015-06-03
- Posted by FDA
- 2015-06-10
- Terminated
- 2016-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1114-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.