USFDA 21CFR Part 7 Subpart C Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities (21 CFR 7.40 – 7.59).
EuropeQuality Defects and Recall (EMA): Reporting of Product quality defect, including a suspected defect, of a centrally authorised medicine which could result in a recall or abnormal restriction on supply to European Medicines Agency (EMA)
