Food Recall Research Articles

Product Recall Decisions and the CEO: Informed Trading in the Medical Device Industry

Product Recall Decisions and the CEO: Informed Trading in the Medical Device Industry

Efficient data acquisition for traceability and analytics

Implementing processes for traceability is required in various industries to assure product quality during manufacturing, provide evidence on required processing conditions or facilitate product recalls. Commonly, radio-frequency identification (RFID) or code recognition techniques (e.g. Data Matrix) are applied to track the flow of workpieces through a manufacturing system and link processing data accordingly. Although the analysis of tracking data is well-examined, we still see a gap in the research on the trade-off between data acquisition, data analytics and data quality. Here, we present a framework to increase the value of existing data by enabling data analytics while addressing common pitfalls and reducing the costs of data management.

The Dynamic Interdependencies Among the Negativity and the Positivity in News and User-Generated Content about Safety in a Firm's Products and the Firm's Product Recalls Forthcoming in PLOS ONE

The Dynamic Interdependencies Among the Negativity and the Positivity in News and User-Generated Content about Safety in a Firm's Products and the Firm's Product Recalls Forthcoming in PLOS ONE

Improving Students' Knowledge of Breakfast Energy and Protein Consumption through E-Booklet Media

Malnutrition remains an important health issue in Indonesia, especially among undernourished children. The current nutrition intervention program, Family Nutrition Awareness, emphasizes the importance of breakfast in combating malnutrition. The purpose of this study was to determine the differences in maternal knowledge, energy, and protein consumption of students before and after counseling on breakfast using e-booklet media. This study used a pre-experimental type with a one-group pretest-posttest design. Maternal knowledge was assessed through a questionnaire, and energy and protein consumption was measured using a food recall form. The statistical analysis used was the paired T-test for normally distributed data and the Wilcoxon test for non-normally distributed data. The results showed significant differences in maternal knowledge and children's energy and protein intake before and after the e-booklet-based educational intervention (p=0.002 and p=0.000). This shows the effectiveness of e-booklets as a nutrition education media, which has the potential to positively influence maternal knowledge and improve children's breakfast habits. In conclusion, there is a difference in nutritional knowledge, energy, and protein consumption before and after counseling on breakfast using e-booklets. This study emphasizes the importance of innovative and accessible educational tools in combating malnutrition in Indonesia.

Comparison of Macronutrient and Micronutrient Adequacy Among Pregnant Women in Urban and Rural Areas

Adequate macronutrients and micronutrients during pregnancy can support optimal fetal growth and development in addition to meeting the needs of the mother to ensure a healthy pregnancy. The region of residence is one of the factors that contribute to determining how nutrition is fulfilled in groups of pregnant women. This study aims to compare the adequacy of macronutrients and micronutrients between pregnant women in urban and rural areas. This study involved 50 pregnant women, 25 in urban areas and 25 in rural areas. Nutritional information was obtained using a food recall questionnaire that was assessed for 3 days, namely on 2 working days (not consecutive) and 1 day off and also using a food frequency questioner (FFQ). Data was analyzed using Chi Square and Results showed a difference in carbohydrate (p=0.049) and protein (p=0.045) consumption between urban and rural pregnant women, while energy (p=0.053) and fat (p=0.056) showed no difference in adequacy. For micronutrients, Vitamin A (p=0.043) and B12 (p=0.042) consumption showed differences between urban and rural pregnant women, while for vitamin C (p=0.065), vitamin B1 (p=0.078), vitamin B2 (p=0.084), B3 (p=0.056), B6 (p=0.075), E (p=0.088), Iron (p=0.052), Folic acid (p=0.067), Calcium (p=0.054), Phosphorus (p=0.055), fiber (p=0.079), showed no difference in consumption between urban and rural pregnant women. The consumption of micronutrients and macronutrients of pregnant women in rural and urban areas showed less intake than recommended. Nutrition education needs to be improved not only focusing on pregnant women but also on adolescent groups, pre-conception period so that early on good consumption patterns have been formed which will always be applied throughout life.

Added Sugars Consumption Decreased Iron and Zinc Intake among Children Aged 24-59 Months in Central Java

Background: High sugar consumption was found among children in Indonesia. Excessive intake of added sugars was predicted to cause micronutrient dilution, a negative potential effect compromising micronutrient intake such as iron and zinc. Objectives: This study examined the association between added sugar consumption and iron and zinc intake among children aged 24-59 months. Methods: This study was a secondary data analysis of the 2014 Total Diet Study in Central Java Province. The subjects were 394 children aged 24-59 months. Dietary intake and sociodemographic data were assessed using the 24-hour food recall and household questionnaire. Added sugars consumption was classified into six cut-offs based on its contribution to daily energy (%E), namely: C1 (<5%E), C2 (5%E - <10%E), C3 (10%E - <15%E), C4 (15%E - <20%E), C5 (20%E - 25%E), and C6 (>25%E). Results: 48% of subjects had added sugar intake exceeding the WHO recommendation. Subjects with iron and zinc intake below the Estimated Average Requirement (EAR) were 15.2% and 24.1%, respectively. As the added sugar consumption increased, iron and zinc intake decreased significantly (p<0.05). This study found a significant decrease in the intake of iron occurred at added sugar consumption ≥20%E (C5 and above) while decreasing the intake of zinc at added sugar consumption ≥15%E (C4 and above) (p<0,05). Conclusions: Added sugar consumption had an inverse association with iron and zinc intake among children aged 24-59 months, which showed the occurrence of micronutrient dilution.

Nutrient Intake Associated with Anemia Status of Primary School Children

This study aims to analyzse nutrient intake associated with the anemia status of primary school children in Bogor, Indonesia. A cross-sectional study was conducted on 500 children aged 8–14 years from 16 primary schools in Bogor, Indonesia. Anemia status was determined using hemoglobin level and analyzed using the cyanmethemoglobin method. Meanwhile, the dietary intake was assessed using 3x24 hours food recall. Anemia prevalance is 58.8%. Most of the subjects had indequate energy and nutrient intake. In this study, vitamin C adequacy level is the only nutrient associated with anemia status (p=0.03; OR=2.3; 95% CI:1.1–5.1).

Association between Pre-Conception Health and Nutrition Knowledge- Attitude-Practice and Anemia among Pre-Marital Women in Sleman, Indonesia

The study aimed to assess the association between pre-conception health and nutrition Knowledge-Attitude-Practice (KAP) and anemia among Pre-Marital Women (PMW). In this cross-sectional study, Mid-Upper Arm Circumference (MUAC) measurement, 24-hour food recall interview, blood sample collection, and validated KAP questionnaire interview were conducted to 111 PMW in Sleman in 2021. The study found that 21.6%, 14.4%, and 49.1% of PMW had Chronic Energy Deficiency (CED), anemia, and lack of minimum dietary diversity, respectively. The proportions of PMW with adequate KAP were 70.5%, 67.8%, and 64.3%, respectively. Pre-conception health and nutrition practices are associated with anemia (p<0.05), but knowledge and attitude are not.

THE EFFECT OF FOOD ACQUISITION OUTSIDE EXPENDITURES ON THE FOOD SECURITY OF CASSAVA (Manihot utilissima) FARMER HOUSE- HOLDS IN WONOGIRI REGENCY

As the standard of living increases, the orientation of food consumption shifts from fulfilling intake to fulfilling nutrition. The acquisition of sustenance by means other than farming and government aid can enhance nutritional satisfaction, increasing energy consumption as a measure of food security. This study aimed to assess the impact of food acquisition outside expenditure on the food security of cassava farmer households in Wonogiri Regency. The research was conducted in July 2022. The method of analysis was descriptive quantitative with purposive location determination. A representative sample of 80 households was chosen by applying the proportionate allocation formula. Data were collected using 2 x 24-hour Food Recall. The data analysis in this study focused on three key variables: income, the proportion of food spending, and the Wilcoxon test of energy consumption and food security among farmer households. These variables were examined before and after food acquisition from external sources. The results showed that the average monthly income of farmers was Rp4,985,487.00. The proportion of food expenditure amounted to 33.36 percent. Wilcoxon test showed a significant difference in energy consumption before and after food acquisition outside expenditure. The food security classification of cassava farmer households before the acquisition of food outside expenditure showed that 21.25 percent were classified as food secure, 15 percent were classified as food susceptible, 52.5 percent as food insecure, and 11.25 percent as severely food insecure. After the additional food outside expenditure, the food security classification increased, with 45 percent classified as food secure, 23.75 percent as food susceptible, 25 percent as food insecure, and 6.25 percent as severely food insecure. This finding demonstrates that food utilization from farming and the Non-Cash Food Assistance (Bantuan et al./BPNT) program positively impacts the food security conditions of cassava farmer households in Wonogiri Regency.

STUDY ON FOOD SECURITY AMONG FARM HOUSEHOLDS PARTICIPATING IN THE SUSTAINABLE FOOD YARD (SFY) PROGRAM IN SEMARANG CITY

Food security in Indonesia can realized when the population’s food needs are met. One of the efforts to increase food security carried out by the Food Security Agency under the Indonesian Ministry of Agriculture is implementing the Sustainable Food Yard (SFY) program or Pekarangan Pangan Lestari (P2L) in Indonesia. The SFY program utilizes yards, idle land, or empty land for agricultural activities. Semarang City includes the regions that have received the SFY program since 2020. This research aims to determine the status of food security and the role of the SFY program on the food security of farm households participating in the SFY program in Semarang City—the research conduct using a survey method on 130 farm household samples. The data collection technique is in the form of interviews using a 24-hour food recall questionnaire. The data obtained was then processed using cross-tabulation analysis between energy sufficiency percentage and food expenditure shared with the Microsoft Excel application to determine the food security status of farm households. The role of the SFY program on the food security of participating farm households was analyzed descriptively. The research results show that the distribution of food security status of farm households participating in the SFY program in Semarang City is 88.46 percent food secure, 3.08 percent vulnerable, and 8.46 percent questionable. The role of the SFY program in the food security of farm households is not very significant in increasing energy consumption and reducing household food expenditure.

Correlation between Macronutrient Intakes (Carbohydrate, Protein, Lipid) and Bone Mineral Density in the Elderly

Osteoporosis is a systemic disease that occurs in bone and is characterized by reduced bone mass and simultaneous damage to bone structure. Osteoporosis commonly occurs in the elderly because of the hormonal mechanism that plays a huge role in bone density. Micronutrients such as calcium and vitamin D have long been recognized as important in maintaining bone structure. Meanwhile, the effect of macronutrient intake on bone density remains unclear. Only a few studies have analyzed the correlation between macronutrient intakes and bone mineral density (BMD) in the elderly. Moreover, the primary data regarding the correlation has not been found in Indonesia. This study analyzed the correlation between macronutrient intakes (carbohydrate, protein, and lipid) and BMD in the elderly. This research is an observational analytical study with a cross-sectional design. Thirty-eight elderly women who met the inclusion criteria underwent an interview with 3 x 24-hour food recall, SQ-FFQ, and examination of bone density using the DXA method. Bivariate analysis using Pearson and Spearman tests was then carried out. Carbohydrate intakes and BMD have a significant negative correlation (p= 0.008), while the correlations of both lipid and protein intake with BMD are insignificant (p> 0.05). There is a significant correlation between carbohydrate intake and BMD in the elderly. On the other hand, there is no significant correlation between protein and lipid intake with BMD in the elderly.

Impact of dietary inflammatory index on gingival health.

Periodontal disease is a biofilm-dependent chronic inflammatory condition triggered by a host response. Several factors impact systemic inflammation and could lead to changes in disease pathogenesis. Recently, studies have assessed the influence of nutritional patterns on the development of periodontitis. In the present cross-sectional study, we evaluated the dietary inflammatory profile on periodontal conditions, focusing on clinical, subgingival microbial, and cytokine assessment of individuals with periodontal health or gingivitis. One hundred patients with periodontal health or gingivitis were included. Plaque index (PI), Bleeding on probing (BoP), the probing depth (PD), and the clinical attachment level (CAL) for each patient were assessed. Nutritional data and the Dietary Inflammatory Index (DII) were recorded by two 24-h food recalls on non-consecutive days. Biofilm and gingival crevicular fluid (GCF) to assess the microbiome profile and inflammatory biomarkers were collected. Multiple regressions focused on the DII, age, and sex as predictors of periodontal conditions were done. Age and moderate DII scores increased the risk of gingivitis by 1.64 and 3.94 times, respectively. Males with an elevated DII score had 27.15 times higher odds of being diagnosed with gingivitis and BoP (β=6.54; p=0.03). Elderly patients with a moderate or high DII score were less prone to gingivitis and increased BoP (p<0.04) compared with younger subjects. Considering the DII, there were no differences in microbial alpha and beta diversity; however, distinct species abundance and a higher concentration of monocyte-chemoattractant protein-1 and interleukin 33 were seen in patients with a higher DII. A pro-inflammatory diet significantly contributes to periodontal inflammation, modulating inflammatory biomarkers and affecting the subgingival microbial community in healthy individuals.

Potency and Powder X-ray Diffraction (PXRD) Evaluation of Levothyroxine Sodium Tablets under Ambient, Accelerated, and Stressed Conditions.

Levothyroxine tablets, although highly prescribed in the United States, have been one of the most frequently recalled products. Because of the importance of the medication, several efforts have been put in place by the United States Food and Drug Administration (US FDA) to control the quality of levothyroxine tablets available to patients using the drug. The choice of excipients used in the formulation has been shown to impact the hygroscopicity and microenvironment, and ultimately the stability of the levothyroxine tablets formulations. Based on information generated from the US FDA Enforcement Report database, one of the main reasons for recalls is the low potency of different batches of the product. The yearly product recall trends for levothyroxine formulations were determined using the FDA Enforcement Report database. Three brands of levothyroxine tablets were selected with excipient lists similar to those products that have been historically recalled. The samples were placed at ambient (~23 °C), accelerated stability (40 °C/75% RH), and stress (50 °C/75% RH) conditions for up to 6 months. Sample potencies were determined at 0, 1.5, 3, and 6 months using the methods for assay and impurities in the United States Pharmacopeia (USP) monograph for levothyroxine tablets. Additional sample monitoring was conducted by overlaying the initial powder X-ray diffractograms (PXRD) of the samples from 0 months with the patterns generated thereafter. There has been a decline in the number of levothyroxine tablets recalled over the years. The highest numbers of recalls were recorded in the years 2013 [33] and 2020 [23]; no recalls occurred in the years 2019 and 2022. All of the brands evaluated met the USP 95.0-105.0% assay requirements at 1.5 months under accelerated conditions; only one of the brands complied at 3 months. Under ambient conditions, two brands were stable at 6 months, with borderline assay results. For stability, levothyroxine was found in microgram quantities in the formulations and PXRD could not detect changes at these low levels. However, we found some distinguishing data for samples under stress conditions.

Relevansi Budaya Keamanan Pangan dengan Implementasi Teknologi Industri 4.0 di Industri Pangan Indonesia

The application of food safety culture (FSC) which is influenced by human behavior with the development of industrial technology (IT) 4.0 with less human resources provides a challenge to understand the relationship between them. The research objective was to provide quantitative data and suggestions for improving the implementation of the FSC dimensions in synergy with the progress of IT 4.0. This research involved 35 participants from 18 local companies and 17 multinational food companies (MFC/PMA) for the survey and invited 7 selected participants from both of them to join the FGD. The FSC survey showed that the gap organizational maturity in FSC implementation between local companies (2.93) and PMA (3.62) in Indonesia was 0.7 (world best practice 4.0 – 5.0). The three main benefits and opportunities for implementing IT 4.0 were effectiveness and efficiency, safe and quality products, and early detection to prevent non-conformities or product recalls. There were three main IT 4.0 application areas, namely production, quality, and engineering. The three main forms of IT 4.0 implementation were advanced robotics, big data, and internet of things (IoT). The FGD results showed the relevance between FSC and IT 4.0. Activities in IT 4.0 helped the food industry to manage food safety and quality management system better, because technical problems that previously took time and thought can be implemented effectively and efficiently. Data analysis can be carried out more in-depth, actual, and accurate. Further research is recommended to see the strength of the relationship between FSC and IT 4.0 parameters to determine critical areas with quantitative research methods and advanced statistical data processing.

Institutional ownership stability and product quality failures

PurposeThis study examines the effect of stable institutional investors on firms' product quality failures. Furthermore, the authors investigate the channels through which institutional ownership stability enhances product quality management.Design/methodology/approachThis study uses probit, ordered probit and negative binomial regression frameworks to investigate the research questions. In addition, the authors utilize the three-stage least-squares to address the endogeneity issues.FindingsUsing a sample of product recall incidents from 2012 to 2021, the authors find that firms with more stable institutional ownership have a lower probability, frequency and severity of recall incidents and adopt a proactive product recall strategy. Institutional investors with significant and persistent holdings improve quality management by reducing overinvestment and the use of option-linked and relative performance executive compensations. Furthermore, the influence of stable institutional owners on product quality failures is more pronounced in firms with low managerial ability and specialist CEOs. Lastly, the empirical evidence demonstrates that stable holdings by active investors have a more substantial impact on reducing product recalls than passive and other stable institutional holdings.Originality/valueThis study is the first to examine the impact of institutional ownership stability on firms' product recalls. The authors contribute to the literature on the benefits of stable institutional ownership on firm outcomes and the determinants of product quality failures.

Hiding operational problems that need to be revealed – a study linking environmental accidents and product recalls

PurposeThis study investigates whether a firm that has experienced an environmental accident (EA) is less likely to conduct a product recall. If true, it would indicate that EAs tempt firms to hide operational problems that need to be revealed. The logic is that both events are operational failures that damage a firm's reputation and share price. Following an EA, a firm may avoid a discretionary product recall to avoid providing additional evidence of operational incapability and social irresponsibility and thereby triggering amplified reputational and market penalties.Design/methodology/approachThe dataset is compiled from several public and private sources and includes 4,355 product recalls, 153 EAs and 120 firms from the industries that often recall products, including automotive, pharma, medical device, food and consumer products. The study timeframe is 2002–2013. Empirical models are evaluated using hazard modeling.FindingsResults show that EAs reduce the probability of a product recall by 32%, on average. Effect sizes are larger when accidents are more frequent or more severe and when recalls are less severe. Through post hoc analyses, the study finds support for the proposed mechanism that firms avoid recalls due to reputational concerns, provides evidence that EAs can have a lengthy impact on recall behavior, and shows that firms are more likely to avoid recalls managed by the CPSC and NHTSA than recalls managed by the FDA.Originality/valuePrior studies in operations management (OM) have not examined the impact of one negative event on another. This study finds that EAs tempt firms to hide operational problems that need to be revealed. While recalling fewer defective products is of concern to consumers and regulators, should EAs influence a broader set of discretionary operational decisions, such as closing/relocating a production facility, outsourcing production or conducting a layoff, study implications increase significantly.

Is there life after product quality failures? Evidence from employment decisions

Prior literature has documented that product quality failures have negative impacts on the interest of stakeholders, such as consumers and shareholders. We extend this literature by investigating its potential effects on the interest of employees. Using a novel dataset that tracks the recall incidents of Chinese firms in an industry where product quality is crucial (i.e., the drug industry), our empirical results show that the effects on corporate employment decisions are twofold. On the one hand, we show that firms’ employment growth decreases after product recalls. The effect is more pronounced in non-state-owned firms, firms with higher labor costs, firms in regions with weaker labor protection, and during periods when local politicians lack promotion incentives. On the other hand, product recalls mainly induce firms to reduce the employment growth of low-grade employees, consistent with recalling firms relying on high-skilled labor to improve drug quality. Collectively, our study suggests that product quality failures could be a broader issue of corporate social responsibility (CSR) than being documented, and carries implications for policymakers concerning employment as well as product safety.

THE U-SHAPED RELATIONSHIP BETWEEN DAILY ENERGY INTAKE AND ALL-CAUSE MORTALITY IN US ADULTS

Abstract The association between low energy intake and longevity observed in non-human studies has not been confirmed in large-scale human investigations. Therefore, we determined the associations between daily energy intake and all-cause mortality in US adults. We included 33,094 US adults (age&amp;gt;19 years) from the National Health and Nutrition Examination Survey (2003-2018). Total energy intake was obtained from 24-hour food recalls and mortality was determined through December 2019 using the National Death Index. Survey-weighted multivariable Cox proportional hazard models were used to calculate all-cause hazard ratios (HR) across categories of energy intake. HR models were stratified by age, sex, race, and BMI, while controlling for potential covariates. During a median follow-up of 96 months, 4,162 participants died. Low energy intake (&amp;lt; 1,000 kcal/day) was associated with higher mortality (HR=1.53 [95% CI 1.26-1.86]) vs. the reference category (2,000-2,500 kcal/d) independent of age, sex, race, BMI, and income. Similarly, low energy intake was associated with higher mortality risk (P&amp;lt; 0.05) in middle-aged (40-64y) and older (≥65y) adults, men, women, and Whites. We observed the same negative associations between energy intake and mortality in normal-weight (18.5-24.9 kg/m2), over-weight (25.0-29.9), and obese (≥30.0) individuals (P&amp;lt; 0.05). The only exception was in Blacks, where lower energy intake was associated with lower mortality (HR=0.75 [0.57-0.99]). Higher energy intake (≥4,000 kcal/d) was also associated with higher mortality, though HRs were not significant, except in young (20-39y), women, and normal weight adults. Our result showed a U-shaped relationship between total energy intake and mortality, like the observed relationship between BMI and mortality.

The effects of innovation on product recall likelihood

Although the consequences of product recalls are well-documented in the literature, literature on the antecedents of recalls is lacking. This study investigates the effects of innovation practices on the likelihood of product recalls in the automotive industry. In doing so, we assess if pushing too hard on innovation can increase the risks that trigger recalls. We assess this potential by leveraging 284 make-year observations. The results demonstrate that innovation radicalness and product line breadth are positively associated with recalls. Furthermore, previous recall magnitude moderates the relationship between innovation radicalness and subsequent recalls. The authors find that the interaction of innovation radicalness and previous recall magnitude increases subsequent recalls, suggesting that firms that are already struggling with recalls can fall further behind by taking risks with their innovation strategy. The managerial and theoretical implications are discussed.

Fat Intake in Overweight Adolescents with Health Belief Model Approach

Obesity in childhood is associated with early mortality, psychiatric, and cardiometabolic comorbidities, and is likely to remain into adulthood. One of the most often utilized models in health-related research to describe and predict behavioral health is the Health Belief Model. The current research aims to ascertain the link between adolescent fat intake and all HBM components. The design of this study was cross-sectional. Purposive sampling was the sampling method, and 110 participants from 4 secondary schools were included. The research data were analyzed using SPSS 27. Measurement of fat intake using a 24-hour food recall interview with two repetitions on non-consecutive days. HBM measurement using questionnaires with 59 questions representing 6 HBM constructs. The bivariate test was performed with the Spearman and Pearson tests. Variables significantly related to fat intake are cues to action and self-efficacy. The higher the cues to action, the lower the adolescent fat intake. Likewise, the higher the self-efficacy, the less fat intake in adolescents. HBM-based education is needed to increase adolescents' perceptions and beliefs regarding health problems, especially overweight, to support handling overweight issues in adolescents.