Fresenius Medical Care Holdings DELFLEX, Dextrose Peritoneal Dialysis Solution with attached recall — FDA D-0512-2026
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lack of assurance of Sterility: potential product contamination
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Multi-state outbreak of E. coli O157:H7.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *
Undeclared allergens (sesame and soy)
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Multi-state outbreak of E. coli O157:H7.
Potential contamination with pesticides, haloxyfop and thiamethoxam
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers…
Potential contamination with pesticides, haloxyfop and thiamethoxam
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
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