Industry

Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled

Drug recall: Understanding the classifications of drug recall is crucial. In this instance, a Class II recall has been enforced.

The Health Master

October 14, 2023

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Last Updated on December 31, 2023 by The Health Master

Drug recall

In a recent development, Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus Lifesciences, has initiated this drug recall of 7,248 bottles of Oxybutynin Chloride extended-release tablets in the United States.

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This action stems from concerns raised by the US Food and Drug Administration (USFDA) regarding manufacturing irregularities.

The tablets, primarily prescribed for overactive bladder and related urinary conditions, are being recalled due to “Failed Dissolution Specifications”.

Understanding the Recall

1. Background

Zydus Pharmaceuticals (USA) Inc., based in New Jersey, produced the affected lot at their Ahmedabad facility. The distribution of this batch was primarily in the United States, overseen by the same company.

2. Nature of the drug Recall

The drug recall has been classified as a Class II recall by the USFDA.

In such cases, the use or exposure to the product may lead to temporary or medically reversible adverse health consequences. However, the likelihood of severe adverse effects is considered remote.

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Regulatory Compliance in Drug Recall

1. Classifications and Protocol

Understanding the classifications of drug recall is crucial. In this instance, a Class II recall has been enforced.

It’s essential to adhere to established protocols during a recall to ensure safety and compliance.

2. FDA Warning Letter for Drugs

Compliance with the USFDA’s regulations is imperative. A failure to do so might lead to the issuance of a warning letter, signifying serious consequences for non-compliance.

3. Patient Notification

Prompt and transparent communication with patients is fundamental. Ensuring they are aware of the recall, its reasons, and the steps to take is crucial for their safety.

4. Handling Drug Recalls in Pharmacy

Pharmacies play a pivotal role in the recall process. Properly managing the return of affected products and communicating with patients are vital responsibilities.

Ensuring Pharmaceutical Quality Assurance

1. NSQ Drugs Identification Guidelines

Adhering to the National Stringent Quality (NSQ) drugs identification guidelines is essential. This ensures that the identification process is accurate and effective.

2. NSQ Samples Testing Procedures

A robust testing procedure for samples is imperative. Rigorous testing helps in identifying issues early, ensuring that only safe and effective drugs reach the market.

3. NSQ Drugs Regulatory Compliance

Compliance with NSQ regulations is paramount. It involves a comprehensive understanding of the guidelines and adherence to the stipulated standards.

4. NSQ Drugs Recall Procedures

Having effective recall procedures in place can make a significant difference. Quick and organized recalls mitigate potential harm to patients and maintain regulatory compliance.

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.