KABIVEN [ — Class II drug recall D-1114-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2015-06-10, distributed nationwide. Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
| Recall number | D-1114-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2015-04-28 |
| Classified | 2015-06-03 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 5,488 bags |
| Reason classes | labeling, potency |
| NDC | 63323-0712, 63323-0712-10, 63323-0712-15, 63323-0712-20, 63323-0712-25 |
| Lot numbers | 10HH8739, 10HH8781 |
| Expiration dates | 2016-07 |
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.
Reason for recall
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1114-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.