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240 result(s) for "Product Recalls and Withdrawals"
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Outbreak of Listeriosis in South Africa Associated with Processed Meat
A total of 937 cases of listeriosis associated with consumption of the processed meat polony were identified in South Africa. Pregnant girls and women, neonates, and persons infected with HIV-1 were disproportionately affected. Molecular techniques identified cases associated with this event and the source of the contamination.
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
This article examines the dynamic interdependencies among the negativity and the positivity in news and user-generated content about safety in a firm’s products (or the lack thereof) and the firm’s product recalls. The authors use a panel vector autoregression (PVAR) to unearth theoretically novel and managerially relevant asymmetric associations. Specifically, they find that the negativity in the news negatively correlates with recalls, whereas the negativity in UGC positively correlates with recalls. Whereas the positivity in the news positively correlates with recalls, the positivity in UGC does not matter. Further, the negativity in the news and the negativity in UGC substitute for each other, whereas their positive counterparts complement each other’s associations with recalls. Lastly, the negativity and positivity in the news have significant, though differently patterned, long-term associations with recalls. The findings contribute to research on the associations between earned media and managerial decisions in the product market.
Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research
The FDA’s Center for Drug Evaluation and Research has recommended withdrawing the approval of Makena for the prevention of recurrent preterm birth after a trial failed both to verify clinical benefit to neonates and to substantiate a reduction in preterm birth.
Outbreak of hepatitis A in the USA associated with frozen pomegranate arils imported from Turkey: an epidemiological case study
In May, 2013, an outbreak of symptomatic hepatitis A virus infections occurred in the USA. Federal, state, and local public health officials investigated the cause of the outbreak and instituted actions to control its spread. We investigated the source of the outbreak and assessed the public health measures used. We interviewed patients, obtained their shopping information, and did genetic analysis of hepatitis A virus recovered from patients' serum and stool samples. We tested products for the virus and traced supply chains. Of 165 patients identified from ten states, 69 (42%) were admitted to hospital, two developed fulminant hepatitis, and one needed a liver transplant; none died. Illness onset occurred from March 31 to Aug 12, 2013. The median age of patients was 47 years (IQR 35–58) and 91 (55%) were women. 153 patients (93%) reported consuming product B from retailer A. 40 patients (24%) had product B in their freezers, and 113 (68%) bought it according to data from retailer A. Hepatitis A virus genotype IB, uncommon in the Americas, was recovered from specimens from 117 people with hepatitis A virus illness. Pomegranate arils that were imported from Turkey—where genotype IB is common—were identified in product B. No hepatitis A virus was detected in product B. Imported frozen pomegranate arils were identified as the vehicle early in the investigation by combining epidemiology—with data from several sources—genetic analysis of patient samples, and product tracing. Product B was removed from store shelves, the public were warned not to eat product B, product recalls took place, and postexposure prophylaxis with both hepatitis A virus vaccine and immunoglobulin was provided. Our findings show that modern public health actions can help rapidly detect and control hepatitis A virus illness caused by imported food. Our findings show that postexposure prophylaxis can successfully prevent hepatitis A illness when a specific product is identified. Imported food products combined with waning immunity in some adult populations might make this type of intervention necessary in the future. US Centers for Disease Control and Prevention, US Food and Drug Administration, and US state and local public health departments.
Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals
After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently.
Ground Turmeric as a Source of Lead Exposure in the United States
Financially motivated adulteration of spices is a longstanding and important public health problem worldwide. In this commentary, we summarize a growing body of evidence indicating that turmeric containing excessive concentrations of lead is available for purchase in grocery stores and that childhood lead-poisoning cases attributable to consumption of contaminated turmeric have occurred in the US.
Recall of Point-of-Sale Marketing Predicts Cigar and E-Cigarette Use Among Texas Youth
Abstract Introduction While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and focused on cigarettes. The present longitudinal study examined recall of tobacco marketing at the POS and multiple types of tobacco use 6 months later. Methods The Texas Adolescent Tobacco Advertising and Marketing Surveillance System (TATAMS) is a large-scale, representative study of 6th, 8th, and 10th graders in 79 middle and high schools in five counties in Texas. Weighted logistic regression examined associations between recall of tobacco advertisements and products on display at baseline and ever use, current use, and susceptibility to use for cigarette, e-cigarette, cigar, and smokeless products 6 months later. Results Students’ recall of signs marketing e-cigarettes at baseline predicted ever e-cigarette use and increased susceptibility to use e-cigarettes at follow-up, across all store types. Recall of e-cigarette displays only predicted susceptibility to use e-cigarettes at follow-up, across all store types. Both recall of signs marketing cigars and cigar product displays predicted current and ever cigar smoking and increased susceptibility to smoking cigars at follow-up, across all store types. Recall of cigarette and smokeless product marketing and displays was not associated with tobacco use measures. Conclusion The POS environment continues to be an important influence on youth tobacco use. Restrictions on POS marketing, particularly around schools, are warranted. Implications Cross-sectional studies have shown that exposure to POS cigarette marketing is associated with use of cigarettes among youth, though longitudinal evidence of the same is sparse and mixed. Cross-sectional studies have found that recall of cigars, smokeless product, and e-cigarette tobacco marketing at POS is associated with curiosity about tobacco use or intentions to use tobacco among youth, but limited longitudinal research has been conducted. Findings from the present longitudinal study suggest that recall of tobacco marketing at retail POS predicts ever use of e-cigarettes and cigars, current use of cigars, and susceptibility to cigar and e-cigarette use among youth.
An Augmented Risk Information Seeking Model: Perceived Food Safety Risk Related to Food Recalls
Food safety is of worldwide concern. As an effective mechanism governing food safety, food recalls are widely applied around the world. Though it is well known that food recalls can have substantial, negative impacts on corporate reputation and marketing, we know relatively little related to what factors motivate people to seek related information after the recall announcement. This study attempts to elucidate the determinants of information-seeking intention in the context of food safety in food recalls by using an augmented risk information-seeking model. A survey of 631 Chinese residents was used to explore the proposed framework. The results show that current knowledge, risk perception, perceived channel beliefs, and perceived information-gathering capacity (PIGC) are all significant predictors of information need and information-seeking intention. It was also confirmed that risk perception has a positive correlation with seeking need. These findings are important for policymakers, recalling manufacturers, and retailers to develop strategies for better risk communication in food recall announcements.
Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports
Purpose 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. Methods 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. Results 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. Conclusion 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.
A Multistate Outbreak of Hepatitis A Associated With Semidried Tomatoes in Australia, 2009
Background. A large outbreak of hepatitis A affected individuals in several Australian states in 2009, resulting in a 2-fold increase in cases reported to state health departments compared with 2008. Two peaks of infection occurred (April—May and September—November), with surveillance data suggesting locally acquired infections from a widely distributed food product. Methods. Two case-control studies were completed. Intensive product trace-back and food sampling was undertaken. Genotyping was conducted on virus isolates from patient serum and food samples. Control measures included prophylaxis for close contacts, public health warnings, an order by the chief health officer under the Victorian Food Act 1984, and trade-level recalls on implicated batches of semidried tomatoes. Results. A multijurisdictional case-control study in April—May found an association between illness and consumption of semidried tomatoes (odds ratio [OR], 3.0; 95% CI 1.4—6.7). A second case-control study conducted in Victoria in October—November also implicated semidried tomatoes as being associated with illness (OR, 10.3; 95% CI, 4.7—22.7). Hepatitis A RNA was detected in 22 samples of semidried tomatoes. Hepatitis A virus genotype IB was identified in 144 of 153 (94%) patients tested from 2009, and partial sequence analysis showed complete identity with an isolate found in a sample of semidried tomatoes. Conclusions. The results of both case-control studies and food testing implicated the novel vehicle of semidried tomatoes as the cause of this hepatitis A outbreak. The outbreak was extensive and sustained despite public health interventions, the design and implementation of which were complicated by limitations in food testing capability and complex supply chains.