Product Recall Procedure
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The documented process for removing or correcting a distributed product found to be defective, mislabeled, or otherwise violative, covering recall classification, notification of health authorities and affected customers, effectiveness of the recall, reconciliation of quantities distributed versus recovered, and closure reporting.
A recall procedure defines who has authority to initiate a recall, how the recall is classified for severity, how affected lots are identified through distribution records, and how customers and, where required, health authorities are notified within regulatory timeframes.
Execution includes an effectiveness check — confirming that notified customers actually received and acted on the recall notice — and reconciliation, comparing quantities distributed against quantities returned, destroyed, or otherwise accounted for, with any unreconciled gap investigated.
A recall is distinguished from a market withdrawal or stock recovery by the presence (or absence) of a violation warranting regulatory notification; the procedure should make that classification decision explicit rather than left to case-by-case judgment during an active event.
- —Defines authority to initiate, classification, and notification timeframes
- —Distribution records must support rapid identification of affected lots
- —Includes an effectiveness check on customer notification
- —Reconciles quantities distributed against quantities recovered
21 CFR Part 7 Subpart C (Recalls); EU GMP Part I Chapter 8; FDA Regulatory Procedures Manual Chapter 7
Frequently asked questions
What is Product Recall Procedure?
The documented process for removing or correcting a distributed product found to be defective, mislabeled, or otherwise violative, covering recall classification, notification of health authorities and affected customers, effectiveness of the recall, reconciliation of quantities distributed versus recovered, and closure reporting.
Which regulations cover Product Recall Procedure?
21 CFR Part 7 Subpart C (Recalls); EU GMP Part I Chapter 8; FDA Regulatory Procedures Manual Chapter 7