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Pharmaceutical Products Recall Guidelines and Procedures | FDA

Recalls are an effective method for removing or correcting marketed products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). 

Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or judicial actions, especially when the product has been widely distributed. 

FDA regulated firms may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, as statutorily mandated or as ordered by FDA. 

All agency components are expected to follow the requirements of  chapter 7 of Regulatory Procedures Manual 2022.



Although this chapter primarily implements 21 CFR Part 7 Subpart C, some deviation from the policy, definitions, responsibilities, and procedures under 21 CFR Part 7 Subpart C may occur with statutorily mandated and ordered recalls. 

See Section 7-5-3. 

These deviations are noted throughout this chapter. 

Guidelines delineating the responsibilities of industry in conducting recalls are in 21 CFR 7.40-7.59. 

It is designed for all FDA regulated industry and provides guidance both in the conduct of recalls and in the information needed by FDA to classify, monitor, and assess the effectiveness of a recall.

This chapter provides definitions, responsibilities, and procedures for agency components to initiate, review, classify, publish, audit and terminate recall actions. 

It implements 21 CFR Part 7 Subpart C – Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibilities. 

See also Investigations Operations Manual (IOM) Chapter 7 - Recall Activities. 

It also discusses FDA non voluntary recalls and includes a reference to the procedures for implementing each of these authorities, including recalls of Medical Devices, Radiation Emitting Electronic Products, Biological Products, Human Tissue Intended for Transplantation, Infant Formula, Tobacco Products, and Food Products.

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