Kabiven Injection, Emulsion
FDA Recall NDC 63323-712
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kabiven (NDC 63323-712). A significant event, classified as Class II, was initiated on Apr 28, 2015 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Apr 28, 2015
Jun 10, 2015
5,488 Bags
Recall Profile & Regulatory Data
Event ID
71222
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US; Nationwide, including Puerto Rico
Termination Date
May 19, 2016
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.
Batch or Lot Expiration Information
Lot# 1)
Lot# 10HH8781, Expiry: 07-2016; 2)
Lot# 10HH8739, Expiry: 07-2016.
Affected Packages Involved in this Recall
63323-712-10Product
63323-712-15Product
63323-712-20Product
63323-712-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
