Clinimix Injection
FDA Recall NDC 0338-7003
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 Clinimix (NDC 0338-7003). A significant event, classified as Class I, was initiated on Nov 18, 2013 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose."
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 I Terminated
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Nov 18, 2013
Mar 26, 2014
7,388 bags
Recall Profile & Regulatory Data
Event ID
67107
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Sep 20, 2016
Product Description
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
Batch or Lot Expiration Information
Lot# P285122, Exp 5/2014
Affected Packages Involved in this Recall
0338-1133-03Product
0338-1089-04Product
0338-1134-03Product
0338-1091-04Product
0338-1137-03Product
0338-1099-04Product
0338-1138-03Product
0338-1101-04Product
0338-0198-01Product
0338-0198-06Product
0338-0188-01Product
0338-0188-06Product
0338-0194-01Product
0338-0194-04Product
0338-0180-01Product
0338-0180-06Product
0338-0184-01Product
0338-0184-04Product
0338-7001-01Product
0338-7001-06Product
0338-7003-01Product
0338-7003-04Product
0338-7005-01Product
0338-7005-06Product
0338-7007-01Product
0338-7007-04Product
0338-7009-01Product
0338-7009-06Product
0338-7011-01Product
0338-7011-04Product
0338-7013-01Product
0338-7013-06Product
0338-7015-01Product
0338-7015-04Product
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.
