KABIVEN [(3.9%) Lipid Injectable Emulsion with recall: Labeling Error
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.
Why was KABIVEN [(3.9%) Lipid Injectable Emulsion with recalled?
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
- 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.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 5,488 Bags
- Distribution
- US; Nationwide, including Puerto Rico
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)