D-1114-2015 Class II Terminated
FDA drug recall D-1114-2015 was initiated by Fresenius Kabi USA, LLC on Apr 28, 2015 and is designated Class II. Reason for recall: Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids The recall status is terminated (terminated May 19, 2016). Affected quantity: 5,488 Bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 10, 2015
- Initiation Date
- Apr 28, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,488 Bags
Product Description
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.
Reason for Recall
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Distribution Pattern
US; Nationwide, including Puerto Rico
Code Information
1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1114-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026