FDA Drug Recall Process
On average, 4500 drugs and medical devices are pulled from shelves across the United States each year, because of product recalls.
Drugs can be recalled, because of a variety of reasons, including issues involving drug contamination, safety, changes in potency, or mislabeling. Although recalls aim to ...
SOP for Product Recall
Purpose: To ensure recall of products that are known or suspected to be defective or hazardous in accordance with a pre-determined plan promptly and effectively from the market.
Scope: This SOP is applicable for all products marketed by (Company Name).
Definitions:
Product Recall: All complaints and ...
