Voluntary Recall Research Articles

Food safety, voluntary recall and firm reputation

AbstractProduct recalls are direct remedies for producers in case of food safety problems. Unlike in the United States or other developed countries, in China, voluntary recalls are rarely documented in the food sector. The purpose of this paper is to address two questions: (1) why do firms adopt different recall strategies in different countries; (2) under what circumstances can voluntary recall help firms build up their food safety reputation? Based on the theory of collective reputation, we develop a dynamic model to incorporate firms' recall strategy and investigate the impact of such a strategy on industry collective reputation. The model takes into account production hazards: producers' lapses in food safety despite good‐faith efforts. Our results show that voluntary recall helps a firm to maintain a good historical record. Hence, firms are likely to achieve a high level of collective reputation under voluntary recall. However, a firm is willing to initiate voluntary recall only if the collective reputation is high enough. This explains the current situation in China: as consumers show little trust (belief in collective reputation is low), firms cannot recover the recall loss and thus have no incentive to initiate a voluntary recall.

Childhood Lead Exposure Linked to Apple Cinnamon Fruit Puree Pouches - North Carolina, June 2023-January 2024.

Lead exposure is toxic even at low levels, resulting in impairments that can affect a child's lifelong success. In North Carolina, testing for lead is encouraged for all children at ages 1 and 2 years and required for children covered by Medicaid; investigations are performed to identify potential exposure sources for children with blood lead levels (BLLs) ≥5 μg/dL. During June-August 2023, routine lead testing identified four asymptomatic North Carolina children with BLLs ≥5 μg/dL. Home investigations identified only WanaBana brand apple cinnamon fruit puree pouches as a potential exposure source; product samples contained 1.9-3.0 ppm of lead. An expanded nationwide investigation led to identification of approximately 500 cases of childhood lead exposure believed to be linked to consumption of apple cinnamon purees, including 22 cases in North Carolina. Fewer than one half (45%) of the 22 North Carolina cases were among children covered by Medicaid. A coordinated multiagency communication strategy was implemented in North Carolina to notify consumers of the hazard and provide recommendations for preventing further exposure. The Food and Drug Administration issued a nationwide public health advisory on October 28, 2023; 2 days later, the manufacturer issued a voluntary recall. Routine testing of young children for lead exposure, combined with thorough environmental investigations, can identify emerging sources of lead exposure and limit further harm.

Trends in varenicline use for tobacco cessation, and their implications

BackgroundTobacco use remains a leading cause of death in the U.S. Varenicline is a preferred medication for tobacco cessation, and a prior report in the literature showed its use fell dramatically after the voluntary recall of Chantix (brand) varenicline (name) in July 2021. ObjectivesWorking with data on prescriptions for varenicline and nicotine-replacement therapy (NRT), we studied use from 2018 to 2023 to determine if varenicline use had recovered or if there had been a compensatory increase in NRT use. MethodsData are yearly from state employees and their dependents who were ≥18 years of age and were health-insurance beneficiaries of the Washington Public Employees Benefits Board from July 2018 through June 2023. Data include numbers of tobacco users and numbers of prescriptions filled. ResultsThe 5-year prevalence of tobacco use among 224,816 beneficiaries was 4.6%. The percentage of tobacco users who filled a prescription for varenicline fell from highs of 9.5% and 9.6% in the 2018–2019 and 2019–2020 years to lows of 5.3% and 6.4% in the 2021–2022 and 2022–2023 years. For nicotine replacement therapy, prescriptions rose modestly over the 5 years, from 4.5% in 2018–2019% to 6.0% in 2022–2023. DiscussionVarenicline use dropped after the voluntary recall of Chantix by Pfizer in mid-2021 and has not returned to prerecall levels. ConclusionPharmacists and other clinicians should address this drop, in addition to addressing longer-term challenges to increasing varenicline use; these include the requirement for a prescription and the black-box warning by the Food and Drug Administration, rescinded in 2016.

Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies. The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.

Impacts of blockchain technology on food supply chains with potential food contamination

Food contamination may have a catastrophic effect on companies, causing a plunge in goodwill. Motivated by the practice that existing voluntary recall strategies still suffer from untimeliness and imprecision, we consider blockchain to provide technical support for food traceability and recall by improving supply chain traceability and transparency. We focus on a two-tier food supply chain facing potential contamination occurrences and build a piecewise deterministic differential game model. We then obtain the optimal strategies of firms and evaluate the impact of contamination events on the dynamic operations of the supply chain. The results show increased contamination likelihood and damage rate, which harm the goodwill of food and optimal decision-making. In addition, we obtain the conditions for the company to be profitable when implementing the blockchain, which is closely related to contamination source identification time, recall efficiency, damage rate, and blockchain cost. Finally, we evaluate several specific cases.

Proust and involuntary retrieval.

Proust was undoubtedly a pioneer in exploring cognitive processes engaged in memory. The analysis of the episode of the madeleine, as well as the study of Proust's statements on the goals of his work, clearly reveal the visionary side of this author. Long before several concepts entered into mainstream scientific thought, Proust proposed, among other things, that recall was a reconstruction, that a sensory cue could provoke a memory recall, and that we should distinguish between voluntary and involuntary memory. Through numerous episodes of "involuntary reminiscence" scattered throughout his work, Proust illustrates a particular form of autobiographic memory recall: a recall that does not involve consciousness and whose starting point is an emotion provoked by a specific cue. This recall, which leads, according to Proust, to a more intense revival of the memory than voluntary recall, has only reached prominence in cognitive science more than 80 years later. Additionaly, Proust underlined the determinant role that emotion may have in this particular form of recall. On the other hand, studies on animals have shown that the presentation of a retrieval cue could induce emotional reactions followed by a facilitation of the memory retrieval associated with the cue. The existence of these data, which support Proust's proposals, should encourage the neuroscience community to further explore, in humans and animals, this form of cue elicited emotion that initiated involuntary recall of autobiographical memory.

Voluntary recall of various eye drops for potential safety reason

Voluntary recall of various eye drops for potential safety reason

Voluntary recall of certain lubricant eye drops due to potential risk of eye infections

Voluntary recall of certain lubricant eye drops due to potential risk of eye infections

Recalls of tattoo and permanent makeup inks in the United States and a follow-up microbiological survey of inks with a previous recall history.

In this study, we collected voluntary recall records of tattoo and permanent makeup ink from the U.S. Food and Drug Administration (US FDA) Enforcement Report Database. The recall records contain information, such as recall date, manufacturer, ink color, reason for recall, and the microorganisms detected from the ink samples. Between 2003 and 2021, a total of 15 voluntary tattoo ink recalls occurred in the U.S. market, involving over 200 tattoo inks marketed by 13 manufacturers and one distributor. Fourteen recalls were due to microbial contamination, and one recall was due to allergic reaction. As follow-up, a microbiological survey of 28 tattoo inks of new batches from seven manufacturers having products that were previously recalled was conducted. Aerobic plate count (APC) and enrichment culture methods based on the FDA's Bacteriological Analytical Manual (BAM) were used to detect microbial contamination. The results revealed that six out of 28 tattoo inks were contaminated with bacteria and were produced by two manufacturers. The level of microbial contamination was less than 250 CFU/g in three of the tattoo inks and between 1 × 103 and 1 × 105 CFU/g in the other three inks. Eleven bacterial isolates were identified, including spore-forming Bacillus-related species and potentially pathogenic species. Overall, this study shows that some tattoo ink products produced by manufacturers with a recall history continue to be contaminated with microorganisms. This highlights the need for ongoing monitoring and quality control of such products.

The Impact of Voluntary Recall on the Trust of Loyal and First-Time Consumers in a High Awareness Brand After a Functional Transgression

Brand transgressions might put at risk some of companies’ most important achievements: a high awareness brand and loyal customers’ trust. High awareness brands may suffer from the effects of a functional transgression on customers’ trust and perception regarding an organization’s capacity to keep its promises, as well as the relationship developed with loyal customers. A common outcome of a product functional transgression is government intervention asking for a product recall. The voluntary recall is an alternative to handle brand transgressions, but less common than mandatory product recalls. This paper adds to the literature by theoretically discussing and empirically analyzing how the relationship status of a first-time or loyal customer with a high awareness brand affects consumers’ trust after a functional transgression. Additionally, it examines the moderation effect of response to a functional transgression on the relation between trust’s components—competence, integrity, and benevolence. Through an experimental study 2 (company’s response: passive strategy; voluntary product recall) × 2 (relationship: loyal; first-time) × between-subjects design, the findings indicate that after a high awareness brand transgression, loyal consumers perceive greater competence, integrity, and benevolence in the brand than first-time consumers. When a transgression is followed by a passive strategy in which the transgressor company is aware of a malfunction and decides not to take any action to remediate the situation, loyal consumers have higher integrity and benevolence-based trust perception than first-time consumers. As voluntary recall takes place, loyal and first-time consumers’ perceptions of integrity and benevolence increase, and first-time consumers reach the same levels as loyal consumers, which suggests voluntary product recall is an effective trust recovery strategy for a high awareness brand.

Multistate Outbreak of Salmonella Thompson Infections Linked to Seafood Exposure — United States, 2021

In July 2021, the Colorado Department of Public Health and Environment (CDPHE) laboratory identified a cluster of five Salmonella enterica serotype Thompson isolates related to one another within one allele difference, using whole genome multilocus sequence typing (wgMLST). These five isolates, submitted to the public health laboratory as is routine process for confirmatory testing of Salmonella, were highly related to those identified in a 2020 multistate investigation, during which traceback was conducted for sushi-grade tuna and salmon; a common supplier was not identified. The 2021 investigation commenced on August 5, 2021, with five patients living in Colorado, and one each in Missouri, Washington, and Wisconsin. During August-December 2021, CDC, CDPHE, public health and regulatory officials in several states, and the Food and Drug Administration (FDA) conducted epidemiologic, environmental, and laboratory investigations of this multistate outbreak of Salmonella Thompson. Isolates were genetically related to one another and to 2020 isolates within zero to one allele difference. Implicated seafood products were traced to a single seafood distributor, in which the outbreak strain was identified through environmental sampling, and in which inspection identified inadequate sanitization and opportunities for cross-contamination of raw fish. The distributor issued a voluntary recall of 16 seafood items with high potential for contamination and completed remediation actions. This outbreak illustrated the importance of effective cleaning and sanitizing procedures and implementation of controls. When multiple products are recalled during an outbreak investigation, collaboration between public health agencies and implicated facilities can help provide food safety information to restaurants, retailers, and consumers, and to ensure disposal of all recalled products.

Quantifying the impact of the Philips recall on patients with sleep apnea and clinicians.

Philips Respironics issued a voluntary recall of positive airway pressure devices used to treat obstructive sleep apnea in June 2021. We surveyed sleep medicine clinicians from the American Academy of Sleep Medicine membership to assess the impact of the recall on clinicians and patients. One hundred thirty-six clinicians participated between June 2022 and November 2022. Participants reported their treatment recommendations for patients affected by the recall, their patients' behaviors regarding the recall, the recall's impact on them as clinicians and on their patients, and the approximate time their patients were waiting for a replacement device. Clinicians most commonly reported first learning about the recall from Philips (25.0%), and patients most commonly first heard about the recall from news sources (34.5%). Most clinicians (62.4%) reported that they recommended patients continue using a recalled device. In comparison, only 9.3% of clinicians reported encouraging patients to stop using their recalled device. Clinicians reported that 59.9% of patients continued treatment with their recalled device, whereas 26.5% stopped treatment. Clinicians reported that over one-third of their patients were still waiting for a replacement machine. Most (86.8%) clinicians reported their stress levels were affected due to the recall, and 91.5% of clinicians reported the recall affected their patients' health and well-being. Most (83.3%) clinicians reported the recall affected their patients' trust in medicine. Clinicians reported that the Philips recall impaired the vast majority of their patients' health and trust in medicine and that many patients were still waiting for replacement devices. Robbins R, Epstein LJ, Pavlova MK, etal. Quantifying the impact of the Philips recall on patients with sleep apnea and clinicians. J Clin Sleep Med. 2023;19(9):1677-1683.

Lobbying and Product Recalls: A Study of the U.S. Automobile Industry

Noting the proliferation of product recalls and extensive use of lobbying in some critical product markets (e.g., automobiles, medical equipment), the authors examine the relationship between lobbying and product recalls. Lobbying does not alter product quality, so an efficiency perspective would suggest no relationship. However, a legitimacy-based institutional theory perspective and associated regulation models suggest that lobbying reduces voluntary firm-initiated and mandatory regulator-initiated recalls. To provide insights into these questions, the current study explores nine years of multisource data from the automotive industry, related to recalls and lobbying. The results, obtained with an instrumental variable approach, support dual impacts of lobbying for reducing both voluntary and mandatory recalls. Defect severity and media coverage moderate the effects, and the data support full indirect moderation, such that the interaction between media coverage and lobbying mediates the interaction between defect severity and lobbying. In terms of effect sizes, approximately $404,367 ($1.66 million) more in lobbying expenditures is associated with one fewer voluntary (mandatory) recall, assuming a typical average recall of 235,638 vehicles. This study highlights lobbying as an important (marketing) tool that automotive companies use to manage their regulatory environment, with deep implications for policy making, research, and practice.

To ask or not to ask: strategic recall, but not spontaneous recall, decreases by the passage of time in 46-month-olds' memory of a unique event.

Children's ability to intentionally recall events lessens with temporal distance to the occurrence. However, little is known about the effects of retention time on memories that emerge spontaneously. We examined spontaneous and strategic retrieval in eighty-one 46-month-olds' memory of a lab event after 1 week (the 1-week Condition) versus 43weeks (the 43-weekCondition) in a between-subjects design, using well-established procedures (Krøjgaard et al., in Consciousness and Cognition 55(91): 105, 2017). While spontaneous recall showed no significant effect of retention, the children's strategic recall was negatively affected: even though the children overall still remembered the event, the children in the 43-week Condition showed reduced voluntary recall compared to the children in the 1-week Condition. To our knowledge, this is the first study to assess spontaneous recall after such a long retention interval. The findings add to existing evidence of two modes of retrieval in early childhood and are of both theoretical and forensic relevance.

Can North American animal poison control center call data provide early warning of outbreaks associated with contaminated pet food? Using the 2007 melamine pet food contamination incident as a case study.

The 2007 melamine pet food contamination incident highlighted the need for enhanced reporting of toxicological exposures and development of a national quantitative disease surveillance system for companion animals. Data from poison control centers, such as the Animal Poison Control Center (APCC), may be useful for conducting real-time surveillance in this population. In this study, we explored the suitability of APCC call data for early warning of toxicological incidents in companion animal populations by using a-priori knowledge of the melamine-related nephrotoxicosis outbreak. Patient and household-level information regarding possible toxicological exposures in dogs and cats reported to the APCC from 2005 to 2007, inclusive, were extracted from the APCC's AnTox database. These data were used to examine the impact of surveillance outcome, statistical methodology, analysis level, and call source on the ability to detect the outbreak prior to the voluntary recall issued by the pet food manufacturer. Retrospective Poisson temporal scan tests were applied for each combination of outcome, method, level, and call source. The results showed that month-adjusted scans using syndromic data may have been able to help detect the outbreak up to two months prior to the voluntary recall although the success of these methods varied across call sources. We also demonstrated covariate month-adjustment can lead to vastly different results based on the surveillance outcome and call source to which it is applied. This illustrates care should be taken prior to arbitrarily selecting a surveillance outcome and statistical model for surveillance efforts and warns against ignoring the impacts of call source or key covariates when applying quantitative surveillance methods to APCC call data since these factors can lead to very different results. This study provides further evidence that APCC call data may be useful for conducting surveillance in the US companion animal population and further exploratory analyses and validation studies are warranted.

The Curious Case of Baby Formula in the United States in 2022: Cries for Urgent Action Months after Silence in the Midst of Alarm Bells

The shortages of baby formula in the US resulting from the voluntary recall of contaminated products and shutdown of manufacturing facility in February led to increases in the national out-of-stock rate of the baby formula from 18 to 70% over the summer of 2022. This study utilizes social media listening and data analysis to examine how online media reactions to the physical shortage changed over time and how the reaction to the shortage differed from to the initial recall announcements. Improved understanding of reactions to emergent issues in foods through this lens may improve communication efficiency to mitigate potential consequences.

Neural Networks Implicated in Autobiographical Memory Training.

Training of autobiographical memory has been proposed as an intervention to improve cognitive function. The neural substrates for such improvements are poorly understood. Several brain areas have been previously linked to autobiographical recollection, including structures in the default mode network (DMN) and the sensorimotor network. Here, we tested the hypothesis that changes in connectivity within different neural networks support distinct aspects of memory improvement in response to training on a group of 59 human subjects. We found that memory training using olfactory cues increases resting-state intranetwork DMN connectivity, and this associates with improved recollection of cue-specific memories. On the contrary, training decreased resting-state connectivity within the sensorimotor network, a decrease that correlated with improved ability for voluntary recall. Moreover, preliminary data indicate that only the decrease in sensorimotor connectivity associated with the training-induced decrease in the tumor necrosis factor α (TNFα) factor, an immune modulation previously linked to improved cognitive performance. We identified functional and biochemical factors that associate with distinct memory processes improved by autobiographical training. Pathways which connect autobiographical memory with both high-level cognition and somatic physiology are discussed.

Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience.

In 2020, Advanced Bionics (AB) announced a recall of two cochlear implant (CI) models, the "HiRes Ultra" and "HiRes Ultra 3D", because of reports of hearing degradation. The present study examines clinical parameters and patient features in cases of device failure and evaluates outcomes after reimplantation. A series of 52 patients implanted with the recalled devices experienced suspected device failure and subsequently underwent revision CI placement at a tertiary academic medical center between December 2019 and November 2021. Consonant-nucleus-consonant scores and individual phonemes increased significantly between patients' preoperative evaluation and primary cochlear implantation. Performance declined significantly before revision and recovered after revision CI placement. Similarly, pure-tone average thresholds improved between preoperative and primary CI, fell before revision surgery, and were corrected with revision implantation. As a group, patients reached their peak hearing performance significantly faster after revision CI (mean ± standard deviation, 53.4 ± 51.8 d) compared with their primary CI (mean ± standard deviation, 260.6 ± 245.9 d). Electrical field imaging performed by AB and device impedance measurements were found to be abnormal in the basally positioned electrodes (electrodes 9-16). Hearing performance degradation is significant in AB Ultra device failures and seems to be linked to the basal-most electrodes in the array. Revision outcomes have been robust, necessitating continued monitoring of affected patients and support for reimplantation procedures. IV.

A Case Report of Ethylene Oxide (EO) Contamination in Ice Cream “Häagen-Dazs”, How in Indonesia?

The availability of a safe food supply for the community is a right that must be fulfilled. One of the food supplies is dairy products such as milk. Milk can be processed into various types of products, including ice cream. On 8 July 2022, the European Union Rapid Alert System for Food and Feed (RASFF) reported a case of Ethylene oxide (EO) contamination in French Häagen-Dazs brand vanilla ice cream with levels exceeding quality standards (maximum of 20 mg/kg). This study aims to disseminate information about chemical contamination of ethylene oxide in ice cream and how the Indonesian authorities respond in to prevent and control the spread of contamination. The Previous case reports on 6 July 2022, authorities in France through RappelConso, and on 7 July 2022, Food Standards Australia New Zealand (FSANZ) published public information regarding the voluntary recall of Häagen-Dazs vanilla flavor ice cream by the manufacturer because it contains EO. Meanwhile, on 8 July 2022, the Singapore Food Agency (SFA) ordered importers to recall the product. In 19 July 2022, The Indonesian government through the Badan Pengawas Obat dan Makanan (BPOM) has withdrawn the vanilla flavored Haagen Dazs ice cream product circulating in Indonesia. The hypothesis that can be formulated on Ethylene oxide contamination in ice cream is the use of pesticides containing EO on vanilla flowers (the raw material for making Häagen-Dazs ice cream with vanilla flavor) leaving a high residue. The Häagen-Dazs ice cream industry must implement a good HACCP system, including a sound and safe selection of raw materials

Does a corporation’s food recall strategy affect its brand image and consumers’ intention to purchase? A study in the context of cereal recall in China

PurposeFood recalls are more potentially harmful than other product recalls. This research aimed to investigate the effect of the recall strategies of food corporations on their brand image and consumers’ purchase intention.Design/methodology/approachThis study adopts a between-subjects experiment of 2 (corporate recall strategy: voluntary recall, mandatory recall) *3 (food recall level (severity): high, medium, low), and recruits 224 consumers involved in cereal product recall in China. The authors inductively examine the effects of voluntary and mandatory recall on consumer perception and behavior intentions in the recall process.FindingsVoluntary recall (vs. mandatory recall) will improve corporate brand responsibility image (vs. brand ability image) and consumers’ purchase intention to focal brand (vs. competitive brand and organic brand). Perceived corporate legitimacy and food safety play a mediating role. The former has a greater positive impact on brand image, and the latter has a more significant favorable influence on purchase intention. Furthermore, recall level has a moderating effect on the association between corporate recall strategy and perceived food safety, but is not significant in the effect of corporate recall strategy on perceived corporate legitimacy.Originality/valuePrevious inconsistent conclusions cannot effectively guide food corporations to manage recall strategies. This paper demonstrates the response mechanism of the recall strategy from the perspective of corporate social responsibility, which is beneficial to food safety crisis management and research.