Clinimix E Injection
FDA Recall NDC 0338-1113
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Clinimix E (NDC 0338-1113). A significant event, classified as Class I, was initiated on Jan 21, 2016 by Baxter Healthcare Company. The reported reason for this action was: "Presence of Particulate Matter: identified as dried skin."
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: identified as dried skin.
Jan 21, 2016
Jun 01, 2016
7,436 bags
Recall Profile & Regulatory Data
Event ID
73118
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 26, 2018
Product Description
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Batch or Lot Expiration Information
Lot# : P333930, Exp 05/31/2017
Affected Packages Involved in this Recall
0338-1142-03Product
0338-1144-03Product
0338-1113-04Product
0338-1145-03Product
0338-1115-04Product
0338-1147-03Product
0338-1123-04Product
0338-1125-04Product
0338-1148-03Product
0338-0202-01Product
0338-0202-06Product
0338-0206-01Product
0338-0206-04Product
0338-0210-01Product
0338-0210-06Product
0338-0214-01Product
0338-0214-04Product
0338-7020-01Product
0338-7020-06Product
0338-7022-01Product
0338-7022-06Product
0338-7024-01Product
0338-7024-04Product
0338-7026-01Product
0338-7026-06Product
0338-7028-01Product
0338-7028-04Product
0338-7030-01Product
0338-7030-06Product
0338-7032-01Product
0338-7032-04Product
0338-7034-01Product
0338-7034-06Product
0338-7036-01Product
0338-7036-04Product
March 2015 Class II Recall: Lack of Assurance of Sterility; increased complaints received for leaks
Recall Number
Class II Terminated
Lack of Assurance of Sterility; increased complaints received for leaks
Mar 23, 2015
Apr 08, 2015
7444 containers
Recall Profile & Regulatory Data
Event ID
70695
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Singapore
Termination Date
Oct 20, 2016
Product Description
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Batch or Lot Expiration Information
Lot# Product code: 2B7722
Lot# : P306365, exp date: 8/31/2015
Affected Packages Involved in this Recall
0338-1142-03Product
0338-1144-03Product
0338-1113-04Product
0338-1145-03Product
0338-1115-04Product
0338-1147-03Product
0338-1123-04Product
0338-1125-04Product
0338-1148-03Product
0338-0202-01Product
0338-0202-06Product
0338-0206-01Product
0338-0206-04Product
0338-0210-01Product
0338-0210-06Product
0338-0214-01Product
0338-0214-04Product
0338-7020-01Product
0338-7020-06Product
0338-7022-01Product
0338-7022-06Product
0338-7024-01Product
0338-7024-04Product
0338-7026-01Product
0338-7026-06Product
0338-7028-01Product
0338-7028-04Product
0338-7030-01Product
0338-7030-06Product
0338-7032-01Product
0338-7032-04Product
0338-7034-01Product
0338-7034-06Product
0338-7036-01Product
0338-7036-04Product
November 2014 Class II Recall: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Recall Number
Class II Terminated
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Nov 25, 2014
Dec 24, 2014
7,220 bags
Recall Profile & Regulatory Data
Event ID
69868
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 28, 2015
Product Description
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Batch or Lot Expiration Information
Lot# Product Code 2B7717
Lot# P311357, exp 12/31/2015
Affected Packages Involved in this Recall
0338-1142-03Product
0338-1144-03Product
0338-1113-04Product
0338-1145-03Product
0338-1115-04Product
0338-1147-03Product
0338-1123-04Product
0338-1125-04Product
0338-1148-03Product
0338-0202-01Product
0338-0202-06Product
0338-0206-01Product
0338-0206-04Product
0338-0210-01Product
0338-0210-06Product
0338-0214-01Product
0338-0214-04Product
0338-7020-01Product
0338-7020-06Product
0338-7022-01Product
0338-7022-06Product
0338-7024-01Product
0338-7024-04Product
0338-7026-01Product
0338-7026-06Product
0338-7028-01Product
0338-7028-04Product
0338-7030-01Product
0338-7030-06Product
0338-7032-01Product
0338-7032-04Product
0338-7034-01Product
0338-7034-06Product
0338-7036-01Product
0338-7036-04Product
Class I Terminated
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Nov 18, 2013
Mar 26, 2014
7,068 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 E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.
Batch or Lot Expiration Information
Lot# : P275883, Exp 10/2013
Affected Packages Involved in this Recall
0338-1142-03Product
0338-1144-03Product
0338-1113-04Product
0338-1145-03Product
0338-1115-04Product
0338-1147-03Product
0338-1123-04Product
0338-1125-04Product
0338-1148-03Product
0338-0202-01Product
0338-0202-06Product
0338-0206-01Product
0338-0206-04Product
0338-0210-01Product
0338-0210-06Product
0338-0214-01Product
0338-0214-04Product
0338-7020-01Product
0338-7020-06Product
0338-7022-01Product
0338-7022-06Product
0338-7024-01Product
0338-7024-04Product
0338-7026-01Product
0338-7026-06Product
0338-7028-01Product
0338-7028-04Product
0338-7030-01Product
0338-7030-06Product
0338-7032-01Product
0338-7032-04Product
0338-7034-01Product
0338-7034-06Product
0338-7036-01Product
0338-7036-04Product
Class I Terminated
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Nov 18, 2013
Mar 26, 2014
14,574 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 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
Batch or Lot Expiration Information
Lot# : P287045, Exp 6/2014
Affected Packages Involved in this Recall
0338-1142-03Product
0338-1144-03Product
0338-1113-04Product
0338-1145-03Product
0338-1115-04Product
0338-1147-03Product
0338-1123-04Product
0338-1125-04Product
0338-1148-03Product
0338-0202-01Product
0338-0202-06Product
0338-0206-01Product
0338-0206-04Product
0338-0210-01Product
0338-0210-06Product
0338-0214-01Product
0338-0214-04Product
0338-7020-01Product
0338-7020-06Product
0338-7022-01Product
0338-7022-06Product
0338-7024-01Product
0338-7024-04Product
0338-7026-01Product
0338-7026-06Product
0338-7028-01Product
0338-7028-04Product
0338-7030-01Product
0338-7030-06Product
0338-7032-01Product
0338-7032-04Product
0338-7034-01Product
0338-7034-06Product
0338-7036-01Product
0338-7036-04Product
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.
