Baxter Healthcare 10% Premasol Injection Recall: Yellow Discoloration Risk
Baxter Healthcare recalls 2000mL bulk 10% Premasol sulfite-free injection due to yellow discoloration from oxidation. This may indicate damaged overpouch. Check NDC 0338-1130-06 and lot P33361: 4/30/17.
Lower-risk recall
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
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What happened, in plain English
Baxter Healthcare is recalling 2000 mL bulk 10% Premasol sulfite-free injections because customer reports show yellow discoloration. This discoloration results from oxidation of tryptophan due to a damaged overpouch. The issue does not pose a safety risk but may indicate product degradation. Read more at govinfonow.com/recall/42138-baxter-healthcare-10-premasol-injection-recall-yellow-discoloration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42138-baxter-healthcare-10-premasol-injection-recall-yellow-discoloration-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0425-2017
Cite this page
“Baxter Healthcare 10% Premasol Injection Recall: Yellow Discoloration Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42138-baxter-healthcare-10-premasol-injection-recall-yellow-discoloration-risk. Based on FDA recall #D-0425-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0425-2017%22&limit=1).
Why it’s dangerous
Yellow discoloration occurs when the amino acid tryptophan oxidizes due to a damaged overpouch. This is a sign of product degradation but does not cause injury or illness.
Who’s affected
Healthcare professionals who use this injection for medical purposes. Patients receiving this injection under a prescription are most at risk if they notice discoloration.
How to tell if you have this one
Check for yellow discoloration in the 2000 mL bulk 10% Premasol sulfite-free injection. The product has NDC 0338-1130-06 and lot number P333617, expiring 4/30/17.
- Brand
Baxter Healthcare- Category
Drug
What to do — step by step
Check for Yellow Discoloration
Inspect the injection solution for yellow coloration, which indicates oxidation from a damaged overpouch.
How this recall unfolded
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0425-2017 (December 6, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0425-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.