Which statement is true about recalls and device and drug definitions?

• A. Recalls are actions taken by a firm to remove a product from the market
• B. Recalls are always initiated by FDA orders
• C. Recalls require court approval to proceed
• D. Recalls never involve shipments or lots

Answer: (A)

Recalls are actions taken by a firm to remove a product from the market or to correct it because of safety concerns. This definition is true for both drugs and devices, and it highlights that the initiator is the manufacturer, not the FDA, even though the FDA may request or require such action. Often recalls are voluntary and target specific lots or shipments so only the affected units are pulled or corrected, rather than the entire product line. In contrast, recalls are not always initiated by FDA orders, they don’t require court approval, and they typically involve identifying and handling the affected shipments or lots, so saying they never involve shipments or lots isn’t accurate. Therefore, the statement that recalls are actions taken by a firm to remove a product from the market best captures the concept.