FDA (Drugs) recall action 87907
The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
Temperature Abuse: Product exposed to temperature outside specified limits.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.
Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.
Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.