CHAPTER § 1.05 Product Recalls

• Jurisdiction: United States

§ 1.05 Product Recalls

[1] Introduction

[a] Definition

Recalls generally refer to actions taken by a company to remove a particular product, or products, from the market.⁴⁰⁶ FDA regulations define "recall" as "a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the Agency would initiate legal action, e.g., seizure."⁴⁰⁷ In turn, the term "correction" refers to the "repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location."⁴⁰⁸ Thus, a recall can occur even if the drug product is not physically returned to the sponsor.

[b] Classification

FDA classifies recalls into three categories—Class I, Class II, and Class III. A Class I recall is the most serious of the three; it occurs when there is a "reasonable probability" that use of the product "will cause serious adverse health consequences or death."⁴⁰⁹ Class II recalls involve products whose use "may cause temporary or medically reversible adverse health consequences" or situations in which "the probability of serious adverse health consequences is remote."⁴¹⁰ Class III recalls pose the least danger to public health and occur when use of the recalled product "is not likely to cause adverse health consequences."⁴¹¹ Though the sponsor may decide to initiate the recall, FDA assigns the recall to one of these categories, based on the report of an ad hoc committee created to evaluate the potential health hazards posed by the product subject to recall.⁴¹²

Distinct from recalls, market withdrawals occur when either a minor violation of FDA requirements has occurred that would not typically subject a firm to legal action or no violation has occurred, but the sponsor nevertheless withdraws the product from the market.⁴¹³

[2] When Recalls Are "Required" by FDA Regulation

FDA has limited authority to mandate or order a firm to recall its products. More specifically, when certain criteria are met, FDA has mandatory recall authority over medical devices,⁴¹⁴ biological products,⁴¹⁵ human tissue intended for transplantation,⁴¹⁶ infant formula,⁴¹⁷ tobacco products,⁴¹⁸ and foods,⁴¹⁹ but it does not have mandatory recall authority over drugs.⁴²⁰ Thus, all drug recalls are technically voluntary. However, FDA can request a recall when it determines that a regulated product in distribution presents a "risk of illness, injury, or gross consumer deception" that necessitates agency action to protect public health.⁴²¹ FDA typically requests recalls in urgent situations where FDA has evidence to support formal legal action, such as seizure.⁴²² While a firm may disregard an FDA-requested recall, it does so at the risk of a subsequent FDA enforcement action.

[3] The Recall Process

Although firms are requested to notify FDA of voluntary recalls,⁴²³ there is no affirmative duty under FDA regulations to do so. However, it is industry practice to comply with this request for several reasons. First, the failure of a manufacturer to notify FDA will likely raise questions about the firm's commitments to protect the public health and may lead to substantially greater scrutiny, potentially even formal investigations into the firm's compliance status. Second, without FDA notification and input, the agency may later decide that the firm-initiated recall was inadequate or ineffective and demand that the company take additional actions, including a second recall.⁴²⁴ When a sponsor notifies FDA of a proposed recall, the notification should include the following information:

(1) Identity of the product involved;
(2) Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered;
(3) Evaluation of the risk associated with the deficiency or possible deficiency;
(4) Total amount of such products produced and/or the time span of the production;
(5) Total amount of such products estimated to be in distribution channels;
(6) Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts;
(7) A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued;
(8) Proposed strategy for conducting the recall;
(9) Name and telephone number of the firm official who should be contacted concerning the recall.⁴²⁵

With specific regard to the recall strategy, the recalling firm should inform FDA about the depth of the recall, any public warnings the sponsor intends to issue, and the methods used for effectiveness checks.⁴²⁶ Effectiveness checks are intended "to verify that all consignees at the recall depth specified by the strategy have received notification . . . and have taken appropriate action."⁴²⁷ FDA regulations define "consignee[s]" as "anyone who received, purchased, or used the product being recalled."⁴²⁸ Five levels of effectiveness checks are available, varying from contacting 100 percent of consignees (Level A) to conducting no effectiveness checks (Level E).⁴²⁹

FDA reviews the information submitted by the sponsor and assigns a recall classification, provides recommendations for altering the recall strategy, and informs the sponsor that the recall will be listed in FDA's weekly Enforcement Report.⁴³⁰ Additionally, if a sponsor lacks the resources or ability to complete the effectiveness checks, FDA will assist the firm in the completion of such checks.⁴³¹

The sponsor's additional responsibilities include notifying "affected direct accounts" about the recall⁴³² and submitting periodic recall status reports to FDA.⁴³³ FDA decides how often the sponsor must submit recall status reports, depending on the urgency of the recall.⁴³⁴...