Review Article Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history Upendra Nagaich, Divya Sadhna1 Departments of Pharmaceutics and 1Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India Abstract There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company’s discovery, customer’s complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm’s recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. Key words: Drug product recall, guidelines, process, recall information INTRODUCTION Regardless a company’s best exists that dangerously defective drug product may reach the customers. These products may cause A drug recall is an instance to return to the maker a batch or disasters, leading to adverse verdicts in drug product liability an entire production run of a drug product, usually due to the litigations. The quality management of complaints and drug detection of safety issues or drug product defect. When drug product recalls are necessary to ensure the safety of customer.[2] products are known to have potentially harmful effect on users Recalls can be either unconstrained by the manufacturer, or rarely, due to their defective quality, safety or efficacy, they may be injunction by FDA. Recalls vary in severity and in the action that subjected to a recall and all related information’s are reported to must be contracted. It is possible that sometimes a drug company the drug office [Table 1].[1] When Food and Drug Administration may recall only a specific batch or lot. However, there are certain (FDA) found a violation of the laws, it issues a recall orders by other cases when all batches or lots of the drug experience recall which a firm remove or correct the market product. The agency from the market.[3] would initiate legal action if the orders are not followed. There is a team responsible for coordinating all aspects related to product recall. The team is composed of endeavor to design, manufacture PURPOSE and sell safe and reliable products, the probability still a recall coordinator and members from the various functional areas. This review article endows definitions, responsibility and procedure to initiate, review, classify, audit and terminate recall action. It also discusses the major drug recalls, reasons of recalls Address for correspondence: Ms. Divya Sadhna, and strategies to overcome the recalls. Department of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Sector 125, Noida - 201 313, Uttar Pradesh, India. E-mail: [email protected] BACKGROUND Access this article online Recalls are a suitable alternative providence by the FDA Quick Response Code: Website: for removing or correcting marketed consumer products, www.jpionline.org their labeling, and/or promotional literature that violate the laws administrated.[4] Firms may initiate a recall following DOI: notification of a problem by FDA or a state agency, in 10.4103/2230-973X.147222 response to a formal request by FDA, or as ordered by FDA. Manufacturers and/or distributors may also initiate a recall International Journal of Pharmaceutical Investigation | January 2015 | Vol 5 | Issue 1 13 Nagaich and Sadhna: Drug recall at any time to fulfill their responsibility to protect the public • The FDA categorizes the recall action by determining that health from drug products that show a risk of injury or the action meets the definition of the recall. The information gross spoof, or are otherwise defective. The FDA drug recall is reviewed by FDA in detail. and other actions have been classified as the following five • It is the responsibility of FDA to notify the firm about categories:[5] necessary changes in its recall strategy, including the need • Class I recall: Includes a health hazard situation where there for press releases, and the classification of the recall. is reasonable possibility that the use of the product will lead • The recall process is monitored, and audit is carried out to serious, adverse health consequences or death. by FDA so as to ensure that the recall action has been • Class II recall: Includes a potential health hazard situation effective. where there is a remote possibility of adverse health • FDA also determines that when a recall should be consequences from the use of the drug product. terminated. It provides written notification for termination • Class III recall: Includes a situation where the use of action to the recalling firm. the drug product is not likely to cause adverse health outcome. In the case, the firm fails to recall violative product or when recall • Market withdrawal: When a product has a minor violation action fails, FDA may take regulatory action in consultation that would not be subject to FDA legal action “market and co-ordination with the district compliance branch, the withdrawal” occurs. The drug product is removed by the appropriate center recall and compliance staffs. firm from the market or corrects the violation. • Medical device safety alert: Released in circumstances SETTING UP FOR RECALL where a medical device may present an unreasonable risk of substantial harm. These situations also are considered Food and Drug Administration deduces its recall regulations recalls in certain cases. by specifying measures a “rational firm” can take to minimize disruption in the event of a recall.[7] THE RESPONSIBILITY OF FOOD AND DRUG 1. FDA suggests setting and maintaining “current written contingency plan” for use in starting and affecting a ADMINISTRATION recall in accordance with agency guidelines. The “written contingency plan” should be according to the standard The FDA recall curriculum provides sufficient resources operating procedure (SOP) that set forth what steps to process, to classify, and to publicize recalls on time. The must be taken, in what series, and by whom, as soon as responsibility of FDA is:[4] a potential recall situation has been recognized. These • To initiate the recall process, this includes two types of the steps include: voluntary recall: FDA requested, and FDA mandated. a. Evaluation of the information received, • Determine that the action is a recall. The process of recall b. Identification of the nature and source of the problem, involves a planned specific course of action, which addresses: c. Determination of its breadth and depth, • The depth of recall, d. Evaluation of the potential health consequences, • Need for public warning, and e. Decide whether to recall, • Extent of effectiveness checks for the recall. f. Decide whether FDA should be notified, g. Develop a recall strategy, The FDA review and/or recommend changes to the firm’s recall h. Communication of that strategy to FDA and work with strategy, as appropriate. the agency as appropriate to shape it, i. Implement the recall, and Table 1: Difference between drug recall and j. Conduct effective examination. drug withdrawal 2. FDA instructs companies to sufficiently code regulated Drug recall Drug withdrawal drug products in order to make corrective lot identification A drug recall is an In seldom cases, FDA may need to possible and to allow effective recall of all violative lots. act taken by a firm reassess and change the drug product’s 3. FDA encourages the maintenance of drug product to dislodge a drug approval decision. A decision that a drug product from the market should no longer be marketed depends distribution records essential to assist in the location of a that FDA considers upon the nature and frequency of the recalled drug product. These records are kept for a period of to be in violation of adverse events and how the drug’s time that exceeds the drug product’s shelf-life and expected the law. A drug may benefit and risk balance compares use, and that is at least as long as the retention period be recalled due to with treatment alternatives. When FDA factors such as issues recognizes that the drug’s benefits no specified in other exercisable regulations. related to packaging, longer outweigh its risks, the agency manufacturing, or will ask the manufacturer to withdraw The responsibilities for personnel from essentially every division [6] contamination the drug of the company, with prominent roles for Quality Assurance, FDA: Food and drug administration Regulatory Affairs, Legal Counsel, and Senior Management 14 International Journal of Pharmaceutical Investigation | January 2015 | Vol 5 | Issue 1 Nagaich and Sadhna: Drug recall are allotted. It usually helps to identify a core team that would curriculum of task to be taken in conducting a specific manage the recall and assign key individuals decision-making recall, which addresses the depth of the recall, necessity authority at critical points during the process. It may also help for public warnings, and the extent of effectiveness to orchestrate a mock recall to test the effectiveness of the SOP. scrutinize for the recall. Finally, it would be prudent for the firm to review its insurance • The strategy must customize the individual situation of coverage for the recall event.