CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Clinimix E 5/15 sulfite-free (5% Amino Acid recalled
Baxter Healthcare is recalling Clinimix E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with, distributed nationwide in the US. The recall was initiated on 21 Jan 2016 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-0864-2016
- FDA event ID
- 73118
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Clinimix E
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jan 2016
- FDA classified
- 23 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Jan 2016 | Recall initiated by company | |
| 23 May 2016 | Classified by FDA | +123 days |
| 1 Jun 2016 | Published in enforcement report | +9 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: identified as dried skin.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: identified as dried skin.
Which lots are affected?
Lot #: P333930, Exp 05/31/2017
Where was it sold?
Nationwide and Puerto Rico
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 28 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
3 other products · FDA event 73118This product is part of a recall event; the main page for the event is Metronidazole Injection USP, 500 mg recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Metronidazole Injection USP, 500 mg recalled by Baxter HealthcareMetronidazole | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS I | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS II | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Sterility | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | 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 II | Clinimix E 5/20 sulfite-free (5% amino-acid recalledClinimix E | Baxter Healthcare | Sterility | Nationwide |