Tag: fresenius_kabi

Fresenius Kabi Recalls Tyenne® Injection Vials Due to Glass Particles

12 Aug 2026 4:47 p.m. · Source: US Food and Drug Administration

Fresenius Kabi is recalling Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL vials nationwide due to glass particles, posing risks including blood clots and organ damage. The affected lot was shipped between March 3 and March 25, 2026.

Health Business Medical Science Legal Economy Product Recall Pharmaceuticals Fresenius Kabi Tyenne Tocilizumab-aazg Glass Particles Drug Safety Food Recalls FDA Drugs
Fresenius Kabi Recalls Tyenne Injection Vials Due to Glass Particles

12 Aug 2026 8:32 a.m. · Source: US Food and Drug Administration

Fresenius Kabi has issued a nationwide recall for one lot of Tyenne Injection 400 mg/20 mL vials. The recall is due to the presence of glass particles, posing serious health risks including blood clots and organ damage.

Health Business Medical Science Federal Government Fresenius Kabi Tyenne Injection Product Recall Glass Particles FDA Drug Safety Pharmaceuticals Food Recalls Drugs
Fresenius Kabi Recalls Morphine Syringes Over Dilaudid Labeling Mix-up

10 Aug 2026 2:35 p.m. · Source: US Food and Drug Administration

Fresenius Kabi has initiated a nationwide recall for one lot of Morphine Sulfate Injection, USP, Simplist® 2 mg/1 mL. The recall is due to a labeling error where MicroVaults may contain Dilaudid 0.5 mg/0.5 mL, posing serious health risks.

Health Business Medical Science Social Issues Legal Fresenius Kabi Morphine Sulfate Injection Dilaudid Product Recall Labeling Error Drug Safety Pharmaceuticals Food Recalls FDA Drugs
Fresenius Kabi Recalls Morphine Injection Over Life-Threatening Label Mix-up

5 Aug 2026 3:00 p.m. · Source: US Food and Drug Administration

Fresenius Kabi recalls Morphine Sulfate Injection due to a label mix-up, potentially containing Dilaudid. This poses serious risks, including life-threatening respiratory depression and death, especially for vulnerable patients. No adverse events reported yet.

Health Business Medical Science Legal Education Product Recall Fresenius Kabi Morphine Sulfate Dilaudid Labeling Error FDA Patient Safety Food Recalls Drugs
FDA Alerts Public to Serious Infusion Pump Issues with Fresenius Kabi Ivenix Devices

8 Jul 2026 7:10 a.m. · Source: US Food and Drug Administration

The FDA has issued a serious alert for Fresenius Kabi's Ivenix Large Volume Infusion Pumps due to software and touchscreen issues. These corrections address risks of treatment delays or interruptions, with the FDA classifying them as the most serious type…

Health Business Science & Technology Medical Science Computers and Internet Federal Government FDA Fresenius Kabi Ivenix Infusion Pumps Medical Devices Product Recall Software Food Recalls Drugs

Tag: fresenius_kabi

Fresenius Kabi Recalls Tyenne® Injection Vials Due to Glass Particles

Fresenius Kabi Recalls Tyenne Injection Vials Due to Glass Particles

Fresenius Kabi Recalls Morphine Syringes Over Dilaudid Labeling Mix-up

Fresenius Kabi Recalls Morphine Injection Over Life-Threatening Label Mix-up

FDA Alerts Public to Serious Infusion Pump Issues with Fresenius Kabi Ivenix Devices