Stock recovery

Stock recoveries are not recalls and do not need a correction and removal report under 21 CFR 806. The test is strict: once any part of the lot has been released for sale or use, the action is no longer a stock recovery.

Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.

21 CFR, 806.2

Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.

21 CFR, 7.3