Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL recall — FDA D-0081-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Complete FDA and NHTSA recall records dated in December 2024.
These records include useful source details for the selected month.
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP violations.
cGMP Deviations
CGMP violations.
cGMP Deviations
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.