Drug recall: 51k bottles of generic Antibiotic Drug recalled

This Drug recall highlights the importance of ongoing vigilance in manufacturing and quality control processes.

The Health Master

June 9, 2024

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Last Updated on October 15, 2024 by The Health Master

Drug recall

What’s Drug Recall:

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Product: Cefdinir for Oral Suspension (250 mg/5 mL)
Company: Lupin Pharmaceuticals, Inc. (US arm of Lupin)
Reason for Drug Recall: Defective containers lacking seal integrity, posing a potential health risk.
Number of Bottles Recalled: 51,006
Date of Drug Recall Initiation: May 8, 2024
USFDA Classification: Class II Nationwide Voluntary Drug Recall

What is Cefdinir Oral Suspension?

Cefdinir is a generic antibiotic medication prescribed to treat various bacterial infections.

It comes in a liquid form (suspension) for oral consumption.

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Why is the Drug Recall?

The US Food and Drug Administration (USFDA) reports that Lupin Pharmaceuticals, Inc. is recalling over 51,000 bottles of Cefdinir Oral Suspension due to defective containers.

These containers lack proper seal integrity, which could lead to:

Contamination of the medication
Reduced effectiveness of the medication
Potential allergic reactions

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Who Should Be Aware of the Drug Recall?

Patients taking Cefdinir Oral Suspension (250 mg/5 mL)
Healthcare professionals who prescribe or dispense Cefdinir
Parents or caregivers administering Cefdinir to children

What to Do if You Have the Recalled Medication

Stop using the medication immediately.
Contact your pharmacist or healthcare provider for guidance on returning the recalled product and obtaining a safe replacement.
Report any adverse reactions you experienced while using the medication to the USFDA.

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Lupin’s Manufacturing and Distribution

Lupin is a major player in the global pharmaceutical industry, with India being the world’s largest supplier of generic medicines.

Here’s a quick breakdown of Lupin’s reach:

Manufacturing: Mandideep plant in India
Marketing and Distribution (US): Baltimore-based Lupin Pharmaceuticals, Inc.
Global Market Share: Approximately 20% of generic medicines worldwide
Product Range: Over 60,000 generic brands across 60 therapeutic categories
Export Destinations: Over 200 countries, including major markets like Japan, Australia, Western Europe, and the US

Maintaining Patient Safety

Medication safety is paramount. This Drug recall highlights the importance of ongoing vigilance in manufacturing and quality control processes.

Patients are advised to stay informed about potential drug recall and to consult their healthcare providers for any questions or concerns.

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.

Alerts

Drug Alert: NSQ Drugs Lists

Medical Device Alert: Lists

Safety alerts issued by IPC

Drug Recall

Govt Job Alert

CDSCO Guidelines on Drug Recall

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