Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC
Baxter Healthcare recalls 0.9% Sodium Chloride Injection USP 100 mL bags (Rx only) due to CGMP deviations. Affected lots include P380287 expiring 12/2019. No specific remedy is stated in the recall notice.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP 100 mL bags (Rx only) because of CGMP deviations. This means the product may not meet quality standards, though the recall does not specify a remedy. Read more at govinfonow.com/recall/39697-baxter-0-9-sodium-chloride-injection-bags-cgmp-deviations-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/39697-baxter-0-9-sodium-chloride-injection-bags-cgmp-deviations-recall · Updated October 6, 2026 · FDA enforcement record: FDA #D-1128-2018
Cite this page
“Baxter 0.9% Sodium Chloride Injection Bags: CGMP Deviations Recall.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39697-baxter-0-9-sodium-chloride-injection-bags-cgmp-deviations-recall. Based on FDA recall #D-1128-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1128-2018%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in manufacturing quality control processes. This could mean the product does not meet the required standards for safety and effectiveness, though the specific risk is not detailed in the recall.
Who’s affected
Prescription patients who received the recalled lot P380287 (expiring 12/2019) are affected. Healthcare providers using these bags for medical treatments may also be impacted.
How to tell if you have this one
Check for the lot number P380287 on the packaging. The product expires December 2019 and is labeled as 0.9% Sodium Chloride Injection USP 100 mL bags (Rx only).
- Brand
Baxter Healthcare- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number P380287 and expiration date of December 2019 on the packaging.
Questions people ask
Is there a specific remedy for this recall?
The recall notice does not state any remedy.
What is the hazard for this product?
The hazard is CGMP deviations, which could indicate the product does not meet quality standards, though the specific risk is not detailed.
How can I tell if I have the recalled product?
Check for the lot number P380287 and expiration date of December 2019 on the packaging.
Contact Baxter Healthcare
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-1128-2018 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall D-1128-2018 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1128-2018 (August 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1128-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.