Last Updated on December 31, 2023 by The Health Master
Drug recall
Drug recall: In recent developments, prominent pharmaceutical entities, Sun Pharmaceutical Industries and Aurobindo Pharma, have taken proactive measures to recall certain products from the US market due to manufacturing concerns.
These actions are in accordance with the directives of the US Food and Drug Administration (USFDA).
This article delves into the specifics of these recalls, shedding light on the intricacies of regulatory compliance and its crucial role in maintaining patient safety.
Sun Pharmaceutical Industries’ Drug Recall
Product Information:
- Sun Pharma’s US subsidiary is recalling 69,707 cartons of Cequa, a cyclosporine ophthalmic solution used for treating dry eyes.
Reason for Drug Recall:
- The product is being recalled due to being deemed “Subpotent” by the USFDA, highlighting a deviation from the specified potency levels.
Drug Recall Classification:
- The drug recall falls under Class III, a classification indicating that the use or exposure to the product is not likely to cause adverse health consequences according to the USFDA.
Initiation Date:
- The nationwide recall was set into motion on September 7, addressing concerns promptly.
Aurobindo Pharma’s Drug Recall
Product Information:
- Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication prescribed for Parkinson’s disease treatment.
Reason for Drug Recall:
- The drug recall is attributed to “Failed dissolution specifications,” signaling a deviation from the established dissolution requirements.
Drug Recall Classification:
- This drug recall has been classified as Class II by the USFDA. This classification suggests that while the probability of serious adverse health consequences is remote, there may be a potential for temporary or medically reversible adverse health effects.
Initiation Date:
- The recall process was initiated on August 2 this year, demonstrating a swift response to the identified issue.
The Significance of Regulatory Compliance
The pharmaceutical industry, being one of the largest in the world, demands rigorous adherence to regulatory standards.
Key aspects of regulatory compliance in drug recalls include:
- NSQ Drugs Identification Guidelines: Rigorous guidelines for identifying Non-Standard Quality (NSQ) drugs are essential in promptly recognizing potential deviations from quality standards.
- NSQ Samples Testing Procedures: Robust testing protocols are imperative to verify the quality and safety of pharmaceutical products.
- NSQ Drugs Regulatory Compliance: Ensuring compliance with established regulations is paramount in safeguarding patient well-being.
- NSQ Drugs Reporting Requirements: Transparent and timely reporting of non-compliance issues is essential for regulatory authorities to take appropriate action.
- NSQ Drugs Recall Procedures: Establishing clear procedures for recalls is vital to swiftly and effectively addressing quality concerns.
Note: The information provided is for illustrative purposes only. For specific details and actions related to drug recalls, it is recommended to refer to official statements and communications from the respective pharmaceutical companies and regulatory authorities.
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.
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