CLASS II Drug recall · Reported 24 Dec 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 25 Nov 2014 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-0301-2015
- FDA event ID
- 69868
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Clinimix E
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2014
- FDA classified
- 16 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Nov 2014 | Recall initiated by company | |
| 16 Dec 2014 | Classified by FDA | +21 days |
| 24 Dec 2014 | 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; leaks were observed from the bag seam and port seal
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 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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Which lots are affected?
Product Code 2B7717 Lot # P311357, exp 12/31/2015
Where was it sold?
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 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.
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