Glossary
Returned Products
A medicine sent back to the manufacturer after leaving for the market; destruction is the default where storage and transport history cannot be confirmed, and resale requires assessment by the quality unit.
Details
A returned product is one that left the manufacturer's control and came back: where a recall is the manufacturer calling product in from the market because of a quality defect, a return is product coming back from the distribution chain, and as the EU GMP glossary definition allows, it may or may not be defective. 21 CFR 211.204 requires returned products to be identified and held in quarantine, to be destroyed unless testing or investigation shows they meet appropriate standards where conditions of storage or shipment before or after the return, or the condition of the product, container, or labelling, cast doubt on safety, identity, strength, quality, or purity, and requires records of the product name, labelled potency, dosage form, lot number, reason for return, quantity, date of disposition, and ultimate disposition, with investigation under 211.192 where the reason for return implicates associated batches; EU GMP Chapter 5 §5.70 requires destruction unless there is no doubt about quality, and permits resale, relabelling, or recovery only after critical assessment by the quality control department under a written procedure, taking account of the nature, storage conditions, condition, history, and elapsed time. Inspections cite no return records or no recorded disposition, stock returned to inventory without assessment, and product re-released with no knowledge of its temperature history.
