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Journal of Analytical Toxicology Feb 2021In mid-2019, medical, forensic and legal communities were notified that a certain shipment of evacuated blood sampling tubes were recalled by the manufacturer. This...
In mid-2019, medical, forensic and legal communities were notified that a certain shipment of evacuated blood sampling tubes were recalled by the manufacturer. This recall order described that the preservative sodium fluoride (100 mg) and anticoagulant potassium oxalate (20 mg) were missing from a small batch of 10-mL evacuated tubes. This gave cause for concern for possible implications in criminal justice (e.g., in drink-driving offenses) when blood-alcohol concentrations are interpreted. In reality, the lack of an anticoagulant would have been immediately obvious during sample preparation, owing to the formation of a large clot in the tube when received. Certain impairing drugs (e.g., cocaine and 6-acetylmorphine) are unstable in blood and tend to degrade without an enzyme inhibitor, such as sodium fluoride, present. In reviewing available literature related to current practices and the stability of ethanol in stored blood samples, there does not appear to be a clear consensus regarding the amount of sodium fluoride preservative necessary, if any at all, when blood is taken from living subjects under sterile conditions for typical forensic ethanol analysis.
Topics: Anticoagulants; Automobile Driving; Blood Alcohol Content; Blood Specimen Collection; Chromatography, Gas; Cocaine; Ethanol; Forensic Toxicology; Humans; Morphine Derivatives; Product Recalls and Withdrawals; Sodium Fluoride; Specimen Handling; Substance Abuse Detection
PubMed: 32442269
DOI: 10.1093/jat/bkaa056 -
Europace : European Pacing,... Mar 2011
Topics: Defibrillators, Implantable; Europe; Humans; Product Recalls and Withdrawals; Retrospective Studies; United States
PubMed: 21296772
DOI: 10.1093/europace/eur009 -
Journal of Nuclear Medicine : Official... Mar 2012
Topics: Drug Recalls; Humans; Radiopharmaceuticals; Rubidium Radioisotopes; United States; United States Food and Drug Administration
PubMed: 22393230
DOI: No ID Found -
Medicine and Law Jul 2014In this article the so-called patient recall duty is discussed. More specifically, it has been determined if and when a physician should inform his former patients about...
In this article the so-called patient recall duty is discussed. More specifically, it has been determined if and when a physician should inform his former patients about newly discovered side effects relating to previously executed treatments. Although such an obligation may be surprising there are, in my view, sufficient arguments to justify the duty to perform a patient recall in some cases. The potential objections to the imposition of this duty do not alter my opinion. However, it is by no means the intention to impose on the physician a general post information obligation. In my opinion, two fundamental criteria should be taken into account in order to assess when the physician is obliged to carry out a patient recall, namely: the severity of the potential harm, and the foreseeability of the potential harm. This can be derived from similar existing criteria in other areas in which a recall obligation exists and from the case law concerning patient recall.
Topics: Humans; Physician-Patient Relations; Product Recalls and Withdrawals
PubMed: 27359010
DOI: No ID Found -
Journal of Food Protection Aug 2017Data from the recalls of meat and poultry products from 2000 through 2012 due to Salmonella contamination were used to assess the factors associated with the recovery of...
Data from the recalls of meat and poultry products from 2000 through 2012 due to Salmonella contamination were used to assess the factors associated with the recovery of the recalled product and to develop quantitative models to estimate the number of illnesses prevented by recalls. The percentage of product recovered following a recall action was not dependent on establishment size, recall expansions, complexity of the distribution chain, type of distribution, amount of time between the production and recall dates, or number of pounds of product recalled. However, illness-related recalls were associated with larger amounts of recalled product, smaller percentages of recalled product recovered, a greater number of days between the production date and recall date, and nationwide distribution than were recalls that were not illness related. In addition, the detection of recall-associated illnesses appeared to be enhanced in states with strong foodborne illness investigation systems. The number of Salmonella illnesses prevented by recalls was based on the number of illnesses occurring relative to the number of pounds consumed, which was then extrapolated to the number of pounds of recalled product recovered. A simulation using a program evaluation and review technique probability distribution with illness-related recalls from 2003 through 2012 estimated that there were 19,000 prevented Salmonella illnesses, after adjusting for underdiagnosis. Recalls not associated with illnesses from 2000 through 2012 prevented an estimated additional 8,300 Salmonella illnesses, after adjusting for underdiagnosis. Although further improvements to ensure accurate and complete reporting should be undertaken, our study demonstrates that recalls are an important tool for preventing additional Salmonella illnesses. Moreover, additional training resources dedicated to public health agencies for enhancing foodborne illness detection, investigations, and rapid response and reporting would further prevent illnesses.
Topics: Food Contamination; Foodborne Diseases; Humans; Meat; Poultry Products; Product Recalls and Withdrawals; Salmonella; Salmonella Food Poisoning
PubMed: 28699785
DOI: 10.4315/0362-028X.JFP-16-424 -
Pain Management Nursing : Official... Mar 2011
Topics: Analgesics, Opioid; Dextropropoxyphene; Humans; Safety-Based Drug Withdrawals; United States
PubMed: 21349443
DOI: 10.1016/j.pmn.2011.01.003 -
Lancet (London, England) Feb 2018
Topics: Drug Recalls; Europe; Humans; Hydroxyethyl Starch Derivatives; Plasma Substitutes
PubMed: 29449012
DOI: 10.1016/S0140-6736(18)30255-1 -
Female Pelvic Medicine & Reconstructive... 2019
Topics: Humans; Medical Device Recalls; Pelvic Organ Prolapse; Safety-Based Medical Device Withdrawals; Surgical Mesh; United States; United States Food and Drug Administration
PubMed: 31188175
DOI: 10.1097/SPV.0000000000000747 -
Therapeutic Innovation & Regulatory... Jul 2024This 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...
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.
Topics: Saudi Arabia; Drug Recalls; Retrospective Studies; Humans; Drug Industry; Product Recalls and Withdrawals
PubMed: 38546962
DOI: 10.1007/s43441-024-00635-4 -
BMJ (Clinical Research Ed.) Mar 2012
Topics: Breast Implants; Device Removal; Female; Humans; Prosthesis Failure; Safety-Based Medical Device Withdrawals
PubMed: 22438383
DOI: 10.1136/bmj.e2192