UnratedDrug recall · FDA · Published March 5, 2020
Fresenius Medical Care: Sodium Chloride 0.9% Injection Recall Due to Sterilization Issue
Fresenius Medical Care recalls 1000mL Sodium Chloride 0.9% Injection bags with improper sterilization indicators. This may affect safety during medical use. Contact for details.
“Fresenius Medical Care: Sodium Chloride 0.9% Injection Recall Due to Sterilization Issue.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37345-fresenius-medical-care-sodium-chloride-0-9-injection-recall-due. Based on FDA recall #D-1064-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1064-2020%22&limit=1).
The FDA announced on March 5, 2020, that Fresenius Medical Care Holdings, Inc. voluntarily recalled Sodium Chloride 0.9% Injection, USP, 1000 mL bags due to a cGMP deviation involving improperly positioned chemical indicators during sterilization.
How to tell if you have it
Brand: Fresenius Medical Care
Product: Sodium Chloride 0.9% Injection, USP, 1000 mL bags
Lot #: 19EG02012 (Exp. Date 05/2020), 19EG02019 (Exp. Date 05/2020), 19DG02050 (Exp. Date 04/2020)
Manufacturer: Fresenius Medical Care North America, Waltham, MA
Quantity: 32,592 bags
The hazard
The recall addresses a current good manufacturing practice (cGMP) deviation where chemical indicators were not positioned properly during the sterilization process.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Recent recalls include a Fresenius Bicarby Dialysate leak risk reported on May 12, 2026, and a Fresenius 5008X Blood Tubing Set recall for online port errors on May 11, 2026. Other recent recalls of similar products include Fresenius Kabi Sodium Chloride Injection recalls for lack of sterility assurance on March 11, 2026.
How to tell if you have this one
Check for lot numbers 19EG02012, 19EG02019 (expiring May 2020) or 19DG02050 (expiring April 2020). These bags are for prescription use only and were manufactured by Fresenius Medical Care North America.
Brand
Fresenius Medical Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot numbers 19EG02012, 19EG02019 (expiring May 2020) or 19DG02050 (expiring April 2020) on the bag.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1064-2020 (March 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1064-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.