CLASS II Drug recall · Reported 8 Apr 2015 · FDA Enforcement Report
Clinimix E 5/20 sulfite-free (5% amino-acid recalled
Baxter Healthcare is recalling Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with, distributed nationwide in the US. The recall was initiated on 23 Mar 2015 and the FDA has classified it as Class II.
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-0428-2015
- FDA event ID
- 70695
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Clinimix E
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2015
- FDA classified
- 31 Mar 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Mar 2015 | Recall initiated by company | |
| 31 Mar 2015 | Classified by FDA | +8 days |
| 8 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; increased complaints received for leaks
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Singapore
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; increased complaints received for leaks
Which lots are affected?
Product code: 2B7722; Lot#: P306365, exp date: 8/31/2015
Where was it sold?
Nationwide and Singapore
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
1 other product · FDA event 70695This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection, USP, Viaflex Multi Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 0.9% Sodium Chloride Injection, USP, Viaflex Multi Pack recalledSodium Chloride | Baxter Healthcare | Sterility | 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 |