Over 140,000 Atorvastatin Bottles Recalled, FDA Cites Potential Health Risks – Yahoo

Report on the Recall of Atorvastatin Calcium Tablets and its Implications for Sustainable Development Goals

1.0 Executive Summary

The U.S. Food and Drug Administration (FDA) has announced a Class II recall of over 140,000 bottles of Atorvastatin Calcium tablets, a generic medication for lowering cholesterol. The recall, initiated due to failed dissolution specifications, involves multiple lots manufactured by Alkem Laboratories of India. This event has significant implications for public health and directly relates to the achievement of several United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being) and SDG 12 (Responsible Consumption and Production).

2.0 Recall Details and Health Implications

The recall was classified as Class II, signifying a situation where the use of the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health effects. The primary issue identified was “failed dissolution specifications.”

• Reason for Recall: The tablets failed to dissolve properly during laboratory testing.
• Potential Health Impact: Improper dissolution can reduce the medication’s effectiveness in lowering cholesterol. This poses a risk to patients who rely on the drug to prevent cardiovascular events such as heart disease, heart attacks, and strokes, thereby undermining preventative healthcare measures.

3.0 Analysis of Impact on Sustainable Development Goals (SDGs)

This product recall highlights critical challenges in the global pharmaceutical supply chain and its alignment with the Sustainable Development Goals.

3.1 SDG 3: Good Health and Well-being

The distribution of substandard medication is in direct opposition to the core objective of SDG 3, which is to “ensure healthy lives and promote well-being for all at all ages.”

• Target 3.4: This target aims to reduce premature mortality from non-communicable diseases (NCDs) through prevention and treatment. Ineffective cholesterol medication fails to provide the intended treatment, leaving a significant portion of the approximately 39 million adult Americans who use statins vulnerable and hindering progress toward this target.
• Target 3.8: This target focuses on achieving universal health coverage, including access to safe, effective, quality, and affordable essential medicines. The recall underscores the importance of the “safe, effective, and quality” components of this target. When quality control fails, access to medicine does not translate into improved health outcomes.

3.2 SDG 12: Responsible Consumption and Production

The incident serves as a case study in the failure of responsible production patterns within the pharmaceutical industry, a key focus of SDG 12. The production of faulty medication represents a waste of resources and a failure in quality assurance protocols essential for sustainable production and public health.

4.0 Identification of Affected Products

The recall encompasses Atorvastatin Calcium tablets across four different strengths, distributed nationwide in various bottle counts. Consumers are advised to check the lot numbers and expiration dates of their medication, which range from July 2026 to February 2027.

1. 10-mg Tablets (NDC 67877-511-90, -05, -10)
   • Lot Numbers: 25141249, 24144938, 24144868, 24144867, 24144458, 24143994, 24142987, 24143316
2. 20-mg Tablets (NDC 67877-512-90, -05, -10)
   • Lot Numbers: 25140150, 25140173, 25140172, 24144720, 24144798, 24144692, 24143755, 24143913, 24143754, 24143047, 24142936
3. 40-mg Tablets (NDC 67877-513-90, -05, -10)
   • Lot Numbers: 25140933, 25140477, 24144254, 24144163, 24143995
4. 80-mg Tablets (NDC 67877-514-90, -05)
   • Lot Numbers: 25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, 24143582

5.0 Recommendation

Consumers in possession of Atorvastatin Calcium tablets from the affected lots should contact their healthcare provider or pharmacist for guidance. This action is crucial for ensuring continuity of care and maintaining personal health, which in turn supports the broader public well-being goals outlined in the SDGs.

Analysis of Sustainable Development Goals in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

  This is the most prominent SDG related to the article. The recall of atorvastatin calcium tablets, a medication used to lower cholesterol and prevent serious health conditions like “heart disease, heart attacks, and strokes,” directly impacts public health. The failure of the drug to meet “dissolution specifications” compromises its effectiveness, potentially leading to “adverse health consequences” for the “39 million adult Americans” who use statins. This issue is central to ensuring healthy lives and promoting well-being for all at all ages.

• SDG 12: Responsible Consumption and Production

  The article highlights a failure in the production process. The recall was initiated because the tablets “failed dissolution specifications,” indicating a lapse in quality control by the manufacturer, “Alkem Laboratories of India.” This event relates to ensuring sustainable production patterns, which includes corporate responsibility for product quality and safety. The recall of over 140,000 bottles also represents a significant waste of resources used in manufacturing and distribution, which is contrary to the principles of responsible production.

• SDG 17: Partnerships for the Goals

  The situation described involves international cooperation and regulation. A product “manufactured by Alkem Laboratories of India” was recalled in the United States following an announcement by the “U.S. Food and Drug Administration (FDA).” This demonstrates the role of global partnerships and regulatory bodies in monitoring the safety and quality of goods in the international supply chain to protect public health, which is a key aspect of achieving sustainable development.

2. What specific targets under those SDGs can be identified based on the article’s content?

1. Targets under SDG 3: Good Health and Well-being

   • Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being. The article states that atorvastatin is used for “preventing heart disease, heart attacks, and strokes,” which are major non-communicable diseases. A defective version of this drug undermines the “treatment” component of this target, potentially increasing the risk of premature mortality for patients.
   • Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. The recall directly addresses the issue of “quality” and “effective” essential medicines. The failure of the atorvastatin tablets to meet dissolution standards means that patients did not have access to a quality, effective medicine, which is a core component of this target.

2. Targets under SDG 12: Responsible Consumption and Production

   • Target 12.2: By 2030, achieve the sustainable management and efficient use of natural resources. The production and subsequent recall of “More than 140,000 bottles” of defective medication represent an inefficient use of the raw materials, energy, and labor involved in their creation and distribution, leading to waste.
   • Target 12.4: By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment. The article focuses on the adverse impact on human health due to a failure in managing the quality of a chemical product (the drug). The recall of a faulty pharmaceutical product is a direct consequence of a breakdown in its life cycle management, specifically during the production phase.

3. Targets under SDG 17: Partnerships for the Goals

   • Target 17.16: Enhance the global partnership for sustainable development, complemented by multi-stakeholder partnerships that mobilize and share knowledge, expertise, technology and financial resources. The article illustrates this target through the regulatory action of the U.S. FDA on a product manufactured in India. This cross-border oversight is a form of international partnership aimed at ensuring global health and safety standards.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

Yes, the article contains specific information that can serve as or imply indicators for measuring progress.

1. Indicators for SDG 3

   • Indicator for Target 3.8: The article provides a direct measure of a failure to provide quality medicines. An implied indicator is the number and volume of essential medicines recalled due to quality defects. The article specifies this as “More than 140,000 bottles of atorvastatin calcium tablets.”
   • Indicator for Target 3.4: The article implies an indicator related to the effectiveness of treatment. The statement that the tablets’ failure could reduce their “effectiveness in lowering cholesterol and preventing heart disease” points to the rate of treatment failure or compromised efficacy for non-communicable diseases due to substandard medicines.

2. Indicators for SDG 12

   • Indicator for Target 12.2: The article provides a clear metric for resource inefficiency. The indicator is the volume of wasted products due to production failures. This is quantified as “140,000 bottles” of tablets that must be disposed of.

3. Indicators for SDG 17

   • Indicator for Target 17.16: The article implies an indicator related to the functioning of international regulatory cooperation. An indicator could be the number of regulatory actions taken on imported goods to ensure public safety. The FDA’s recall of a drug manufactured in India is a specific instance of such an action.

4. Table of SDGs, Targets, and Indicators

Source: yahoo.com