openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 8
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: 20NG02095, Exp. Date October 2021
Distribution pattern
Nationwide within the United States
drug · product 2 of 8
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: 20JU01001, Exp. Date February 2022
Distribution pattern
Nationwide within the United States
drug · product 3 of 8
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, Exp. date August 2022
Distribution pattern
Nationwide within the United States
drug · product 4 of 8
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022
Distribution pattern
Nationwide within the United States
drug · product 5 of 8
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: 20SU02032, Exp. date July 2022
Distribution pattern
Nationwide within the United States
drug · product 6 of 8
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
Temperature Abuse: Product exposed to temperature outside specified limits.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Code information
Lot #: 20PU04030, Exp. date June 2022
Distribution pattern
Nationwide within the United States
drug · product 8 of 8
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
