What is a Drug Recall and Why Are Drugs Recalled?

Ensuring patient safety and efficient medication management is an obligation in today’s rapidly evolving pharmaceutical industry. This necessity includes maintaining the delicate balance between innovation and pharmaceutical safety and drug recalls is an integral part of this ecosystem. Pharmaceutical recalls, which can occur at different levels from the consumer level to the distributor level, are swift actions taken to protect public health when drugs fail to meet quality and safety standards. A drug recall, which can be triggered by manufacturing errors, mislabelling or unforeseen side effects, underscores the complexity of drug production and the importance of well-structured tracking and tracing systems. The role of regulatory bodies like the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) is vital in this context; they guarantee that the recall process is conducted in full compliance with safety regulations and provide guidance to minimize health risks. In parallel, logistics and effective communication among stakeholders play a crucial role in ensuring timely recalls, preventing further distribution of faulty drugs and minimizing disruptions to patient safety.  

As Tiga Healthcare Technologies, we overcome the challenges encountered in the pharmaceutical industry through our advanced Pharmaceutical Track and Trace System, branded as DrugXafe. This system, which is a member of our Drug Traceability product family, mitigates risks related to medication errors, empowers stakeholders, navigates the complexities of modern pharmaceutical supply chain management and enables efficient management of the recall process for unsafe or defective medications. DrugXafe and its mobile application enhance patient safety, boost transparency across the entire pharmaceutical supply chain and optimize recall workflows within the industry. 

As a leader in the healthcare IT landscape, we explore the multifaceted aspects of drug recalls in this blog. Today, we answer the question of ‘What is a drug recall?’ by focusing on the reasons for the recall of pharma products, drug recall procedure in supply chain, the impacts of pharmaceutical recalls and actions to be taken during a medication recall. By understanding these dynamics, healthcare professionals, authorities and patients can detect the challenges and responsibilities related to drug recalls, creating a more connected and safer pharmaceutical ecosystem for all.  

What is a Drug Recall?

The FDA identifies drug recall as the most effective way of protecting the general population from a potentially harmful product. A recall of a medicine is an action initiated by a company, either voluntarily or as required by regulatory authorities, to remove a defective pharmaceutical from the market. Additionally, this action includes giving a warning to patients and consumers about the pharmaceutical’s potential risks.  

Pharmaceutical recalls happen when a drug’s developer generally realizes that the drug has problems that could negatively affect human health. Moreover, national and international regulatory agencies may request a drug recall based on various factors, including reports of risky aspects from the public, scientific studies, manufacturing errors, supply chain issues, expiration date concerns or even economic factors. In addition to the request, agencies such as the FDA, EMA and Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety, efficacy and quality of drugs, assess complaints and reports from consumers and companies, facilitate communication with consumers, healthcare providers and distributors during recalls and oversee the proper implementation of recalls. The crucial role of these agencies is to ensure effectiveness and, when necessary, enforce additional actions within drug recalls. 

Pharmaceutical recalls affect all stakeholders of the industry from health authorities to citizens. For example, this action can increase emergency visits, hospitalizations and follow-up treatments due to the adverse effects of the recalled drug. Furthermore, patients might get stressed because of the usage of recalled drugs. This action may also cause financial losses; high expenses related to recalling pharmaceuticals and informing stakeholders can emerge and affected patients or healthcare providers may sue the manufacturer or distributor of a recalled medicine. Because of the lawsuits, patients might switch to alternative brands and pharmaceutical companies lose consumer trust. In addition, regulatory agencies may impose strict compliance measures, audits or penalties on the developers of recalled drugs. Ongoing investigations and regulations have the potential of delaying approval of new medications from the developers. Pharmaceutical recalls impact both individual stakeholders and the entire health ecosystem. This circumstance underscores the significant role of implementing accurate quality assurance measures and maintaining quick response capabilities to detect the potential risk of a medicine.  

The drug recall process generally follows three phases:  

1. Problem Identification and Risk Assessment: This phase involves the identification of the defect or issue with a drug like contamination or labelling error. The risk assessment part includes recall classification which is the evaluation of the drug’s potential risks to public health. The classification varies globally but generally aligns with levels of severity. For example, according to the FDA, Class I recalls indicate that the consumption of the drug may cause adverse health effects and death, Class II recalls reflect temporary or medically reversible risks and Class III recalls state minimal health effects. Although the risk assessment by the EMA is similar to these classifications and the severity is specified, such a clear classification system is not always preferred. Also, the World Health Organization (WHO) offers a comprehensive framework to support drug recall process, but it does not standardize specific classifications. In short, countries conduct a similar risk assessment with some classification differences.
2. Notification and Communication: In the second phase, pharmaceutical firms must inform regulatory authorities like the FDA, EMA and MHRA, healthcare professionals, distributors and the public about the recall. This includes providing clear information on the drug, the issue and corrective actions. Notifications to healthcare professionals, hospitals and pharmacies ensure the prompt identification and isolation of defective products, as well as proper guidance on managing affected patients. Public communication, often carried out through media outlets, pharmacies and healthcare organizations, ensures that end-users are informed about the recall and know how to proceed such as returning or discontinuing use of the product. Transparency and timeliness remain universal requirements to maintain trust and minimize risks.
3. Product Removal and Resolution: The final phase involves the removal of defective products from the supply chain and addressing underlying issues to prevent future occurrences. Controlled destruction ensures that affected pharmaceuticals are removed from pharmacies, distributors and consumers, with an emphasis on environmental compliance and regulatory documentation. In some cases, reconditioning such as replacing incorrect labels with accurate ones allows products to be corrected for safe reuse. Effective supply chain management is critical to confirm the complete removal of recalled items while Corrective and Preventive Actions (CAPA), which is a quality management method used in quality management systems to produce a solution by analyzing the root cause of a problem or potential problem, focus on identifying root causes and implementing improvements in manufacturing and quality processes to avoid similar issues in the future. 

Reasons for Drug Recalls

Some pharmaceutical recalls derive from minor circumstances like labeling which does not correspond to the requirements of the regulatory agency while others depend on serious situations which might reveal significant health risks. In this section, eight common reasons for drug recalls are explained.  

Product Tampering or Counterfeiting 

Product tampering or counterfeiting stands for situations where pharmaceutical products are altered or falsified with the intent to deceive consumers. Counterfeit and substandard drugs can have serious consequences such as ineffectiveness, harmfulness and life-threatening health conditions. Companies should implement strong security measures to detect and prevent counterfeit and substandard medicines to protect public health and their brand integrity. When a counterfeit or substandard drug or such illegal activities are discovered in the supply chain, a drug recall might be initiated to remove the affected products from the market. 

Potential Contamination 

Some drugs may be contaminated during the production or distribution process. This situation means that a harmful or harmless substance which should not belong to a pharmaceutical is involved in the drug. This substance can be bacteria, fungi, heavy metals, other pharmaceuticals and foreign materials like glass particles.  

When a concern about the involvement of potential contaminant occurs, drugs are recalled. Furthermore, relevant agencies might recommend a drug recall if they notice some unhygienic conditions such as the existence of germs at the production facility.  

Adverse Effects 

Adverse effects are known as unexpected and negative responses emerging after taking a drug. These reactions are different from side effects which are more predictable. Unforeseen health effects, serious allergic reactions and long-term safety concerns identified after post-marketing are some of the adverse effects initiating a recall process.  

Recalls based on adverse effects are rarer than other recall reasons. When a simple effect of a drug is encountered, additional warnings and restrictions can be added to the drug’s package. On the other hand, loss of smell, critical brain infections and cardiovascular situations like heart attack after taking a medication underpin a medication recall. 

Mislabelling 

Mislabelling is the presence of inaccurate and misleading information on a drug container. Some examples of mislabelling are missing labels, labels placed on the wrong medicine and labels involving the wrong or confusing expressions of a drug’s amount or concentration. Mislabelling might lead patients to take the inappropriate medication or dose, so drugs with the mislabelling issue are recalled.  

Defective Product 

Defective pharmaceuticals cannot work as intended, so they may be subjected to a recall process. Medical devices which do not release the medication properly, clogged needles on injection pens and syringes, damaged and improperly sealed bottles and packages, missing tamper evident rings and issues with adhesive liners on transdermal patches are considered as defectiveness. Additionally, a drug’s unexpected loss of potency and decomposition or degradation before expiration date may lead to a recall.  

Non-Compliance with Regulatory Standards 

Non-compliance with regulatory standards occurs when a company fails to meet required Good Manufacturing Practices (GMP) which are essential for ensuring product safety and quality. Furthermore, identified issues during regulatory inspections like shortcomings in production and documentation processes and failure to adhere to marketing authorization requirements are examples of non-compliance. These circumstances may result in legal consequences and pharmaceutical recalls, threatening the manufacturer’s reputation and consumer safety.  

Improper Storage or Distribution 

Incorrect storage and distribution significantly decrease the quality and safety of drugs. For instance, failure to maintain proper temperature controls during transport or storage may lead to the degradation of sensitive pharmaceutical products. Logistics errors such as mishandling or delays in the supply chain might also cause poor product quality, affecting efficacy and safety. Ensuring strict adherence to storage and distribution protocols is crucial to preserve the integrity of pharmaceuticals throughout the supply chain. 

Post-Marketing Surveillance  

Post-marketing surveillance involves monitoring the safety and effectiveness of a drug once it has been released to the market. Adverse reactions, safety concerns or unforeseen side effects reported by healthcare professionals or patients can prompt a recall. This ongoing monitoring is essential to ensure that products continue to meet safety standards throughout their market lifecycle. 

What Should You Do During a Drug Recall? 

Prescribed and over-the-counter drugs can be recalled. If an over-the-counter drug you use is recalled, you should firstly stop taking the drug. Additionally, you can return it to the place of purchase and request a refund. You can also consider the below things to have knowledge of recalled drugs and the reasons for recalls.  

Checking the Lot Number 

A recall might affect specific lot numbers, so you should check a pharmaceutical’s lot or batch number which can be found on the medication package. You can check whether your medicine’s lot number is on the list of recalled drugs.  

Communicating with the Pharmacy and Regulatory Authorities 

If you realize that your lot number is on the recall list, you can contact your pharmacist who can replace the medication with an unaffected lot. Additionally, if the recalled product is an over-the-counter drug, your pharmacist might suggest alternatives to it. In such cases, regulatory authorities may also be involved to provide guidance and ensure that affected products are properly removed from circulation. 

Contacting the Prescriber 

The effects of stopping a recalled medication may lead to more serious conditions than the risks associated with the recall. Because of this circumstance, you should communicate with your prescriber who can recommend the continuation or disusage of the medication with the possibility of switching to different treatment.  

Getting Rid of the Recalled Medicine 

When there is a strict instruction for stopping a pharmaceutical, you should dispose of it appropriately. You can get information about the disposal process from the announcement of the regulatory authority. Furthermore, a refund can be sometimes initiated for recalled over-the-counter products.  

Drug recalls are crucial operations involving a coordinated effort across the healthcare ecosystem. Authorities oversee and regulate the recall process while healthcare professionals consider potential risks for patients. On the other hand, pharmacists ensure recalled drugs are removed and manufacturers detect the root cause of the recall and prevent recurrence. Additionally, patients should understand the causes and implications of recalls to act timely and responsibly. Each stakeholder plays a critical role during recalls which increase patient safety and maintain trust in healthcare systems.  

This operation underscores the significance of effective technologies for tracking and tracing pharmaceuticals. At Tiga Healthcare Technologies, we developed DrugXafe and DrugXafe Mobile App based on the importance. This national-scale end-to-end pharmaceutical track and trace system focuses on the WHO’s statement involving that substandard and falsified medical products cause hundreds of thousands of deaths every year. It tracks and traces serialized pharmaceuticals at every stage of the supply chain from production to the end-user and prevents the sale of recalled drugs or lots by providing pharmacists with a notification when an attempt is made to sell these products. It also facilitates the return of recalled items from pharmacists to warehouses and from warehouses to manufacturers. Furthermore, the system can temporarily halt the sale of drugs identified as potentially dangerous even before a formal recall decision is made. In such cases, it informs users about the temporary suspension and, depending on the recall decision, either extends or terminates the suspension process. Additionally, when integrated with our innovative product, Central e-Prescription, which fully digitizes the prescription process, the Pharmaceutical Track and Trace System enhances the capacity of the recall process, adding significant value. When a prescriber attempts to prescribe a recalled medication, the integration prevents the prescription from being processed. Furthermore, once a prescribed drug is dispensed to the patient, the system can track whether the patient has received the recalled drug, as the details of the medication dispensed are linked to the e-Prescription System. This allows for the recall process to be managed on a patient-by-patient basis, even after dispensing, ensuring that patients who have already received the recalled medication are directly notified and their treatment is adjusted accordingly. 

The DrugXafe Mobile App, as a comprehensive and accessible product, provides users with critical drug data like approval status, recall information, expiration data and current price through a simple scan of the 2D Data Matrix on drug packages; it allows users to quickly check recall status and other essential details anytime and anywhere. Additionally, users can report adverse reactions of a pharmaceutical, accelerating a potential recall process and ensuring swift action to protect public health.  

With our innovative products, we pioneer the future of the pharmaceutical industry. Our solutions, which guarantee regulatory compliance, increase operational efficiency and patient safety. Our forward-thinking approach and domain expertise behind these products allows us to set new standards for excellence and accuracy in drug management and beyond.  

Let’s continue to shape a future where digital technologies leverage the pharmaceutical industry together, as always!