Drug recall: Glenmark, Sun recalled these Drugs

The drug recall was initiated on November 7, 2023, and the affected products were manufactured at Glenmark's plant in Goa.

The Health Master

December 4, 2023

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Last Updated on December 24, 2023 by The Health Master

Drug recall

The Indian pharmaceutical sector is currently facing a significant challenge as two prominent players, Glenmark Pharma and Sun Pharmaceutical Industries, undertake drug recall in the US market.

This move comes in response to labeling and manufacturing concerns, as reported by the US Food and Drug Administration (USFDA).

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Glenmark Pharma’s Drug Recall

Indomethacin Capsules

Indomethacin, a nonsteroidal anti-inflammatory drug (NSAID), is widely used to treat mild to moderate acute pain and relieve symptoms of arthritis or gout.

Shockingly, Glenmark Pharmaceuticals had to drug recall 37,200 bottles of Indomethacin capsules due to mislabeling.

These products were incorrectly labeled as Naproxen, a drug with similar purposes.

The drug recall was initiated on November 7, 2023, and the affected products were manufactured at Glenmark’s plant in Goa.

This incident falls under a Class II recall, indicating a remote probability of adverse health consequences from consuming the mislabeled product.

Also read: CDSCO Guidelines on Drug Recall

Sun Pharma’s Drug Recall

buPROPion Hydrochloride Tablets

In another development, Sun Pharma recalled 2016 bottles of buPROPion Hydrochloride Extended-Release Tablets, a medication used in the treatment of depression.

The drug recall was attributed to “Failed Dissolution Specifications,” according to the US FDA report.

The affected drug was manufactured at Sun Pharma’s plant in Halol, Gujarat.

Unlike Glenmark’s drug recall, this incident falls under a Class III recall, suggesting that consuming the product will not cause adverse health consequences.

Click for more on Drug Recall

Significance of Product Recalls

The recent recalls underscore the critical importance of accurate labeling and robust manufacturing processes in the pharmaceutical industry.

These aspects are vital not only for regulatory compliance but also for ensuring public health and safety.

Classifications of USDA Recalls

Understanding the classifications of recalls is crucial.

Class II recalls, as seen with Glenmark’s situation, involve a potential health hazard with a remote probability of adverse health consequences.

On the other hand, Class III recalls, such as Sun Pharma’s, indicate a situation where consuming the product will not cause adverse health consequences.

Click for more articles on USFDA

Company Initiatives

Both recalls were initiated by the respective pharmaceutical companies, Glenmark Pharma and Sun Pharma.

Despite email requests for comments on the matter, responses from both companies are still pending. The article will be updated when the companies provide their insights.

Implications on Consumer Health

The mislabeling of pharmaceutical products raises concerns about potential health consequences for consumers.

Prompt recalls and corrective actions are essential to mitigate any risks and protect the well-being of the public.

Regulatory Role of USFDA

The US Food and Drug Administration (USFDA) plays a pivotal role in monitoring and regulating pharmaceutical products.

Its responsibility includes ensuring that drugs in the market meet stringent safety and quality standards.

Industry Challenges

Maintaining quality control in pharmaceutical production is a challenging task.

Companies must balance the demand for their products with the need to adhere to rigorous regulatory requirements to guarantee product safety.

Public Awareness and Communication

Transparent communication is crucial in situations like these.

Keeping the public well-informed about recalls builds trust and allows consumers to make informed decisions about their health.

Future Preventive Measures

To prevent similar incidents in the future, pharmaceutical companies should implement stringent quality control protocols.

Proactive measures and continuous monitoring can help avoid mislabeling and manufacturing issues.

The Crucial Role of Responsible Person in Pharma: DCC

Conclusion

In conclusion, the recent product recalls by Glenmark Pharma and Sun Pharma highlight the need for vigilance and adherence to quality standards in the pharmaceutical industry.

Proactive measures, transparent communication, and regulatory compliance are essential to maintaining public trust and ensuring the safety of pharmaceutical products.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

What is the significance of the Class II recall for Glenmark Pharma’s product?
- The Class II recall indicates a potential health hazard with a remote probability of adverse health consequences from consuming the mislabeled product.
Why did Sun Pharma initiate a Class III recall for buPROPion Hydrochloride Tablets?
- A Class III recall implies that consuming the product will not cause adverse health consequences. In this case, the recall was due to “Failed Dissolution Specifications.”
How important is transparent communication in pharmaceutical recalls?
- Transparent communication is crucial as it builds trust and allows consumers to make informed decisions about their health during such critical situations.
What role does the US Food and Drug Administration play in pharmaceutical regulation?
- The USFDA plays a pivotal role in monitoring and regulating pharmaceutical products, ensuring they meet stringent safety and quality standards.
What preventive measures can pharmaceutical companies take to avoid recalls?
- Pharmaceutical companies can implement stringent quality control protocols, proactive measures, and continuous monitoring to prevent mislabeling and manufacturing issues.