CLASS I Drug recall · Reported 26 Mar 2014 · FDA Enforcement Report
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid recalled
Baxter Healthcare is recalling Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1159-2014
- FDA event ID
- 67107
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Clinimix E
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 14 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 14 Mar 2014 | Classified by FDA | +116 days |
| 26 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Which lots are affected?
Lot#: P275883, Exp 10/2013
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 27 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 67107This product is part of a recall event; the main page for the event is Clinimix 5/15 sulfite-free (5% Amino Acid recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Clinimix 5/15 sulfite-free (5% Amino Acid recalled by Baxter HealthcareClinimix | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS I | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid recalledClinimix E | Baxter Healthcare | Particulate Matter | Nationwide |
More recalls from Baxter Healthcare
All 573| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Leucine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leucine 10mg/ Isoleucine 15mg/ Valine 40mg/ML recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL vial recalled | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | 10% Premasol sulfite-free (Amino Acid) Injection recalledPremasol - Sulfite-free (amino Acid) | Baxter Healthcare | Undeclared Sulfites | IL |
| Drug | CLASS II | Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS I | Clinimix E 5/15 sulfite-free (5% Amino Acid recalledClinimix E | Baxter Healthcare | Particulate Matter | Nationwide |