Last Updated on June 28, 2024 by The Health Master
Drug recall
Drug recall: Major Indian drug manufacturers, Lupin and Aurobindo Pharma, are recalling medications from the US market following inspections by the US Food and Drug Administration (USFDA) that revealed manufacturing inconsistencies.
This news is concerning for patients who rely on these affordable generic drugs and highlights the importance of strict quality control measures in pharmaceutical production.
Lupin Recalls Cefixime for Oral Suspension
- Reason for Drug Recall: Failed content uniformity specifications, meaning the medication may not contain the consistent amount of active ingredient throughout the batch.
- Product: 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) used to treat bacterial infections.
- Affected Lot: Produced at Lupin’s Mandideep manufacturing plant in Madhya Pradesh, India.
- Recall Classification: Class II, indicating potential for temporary or reversible adverse health effects.
Aurobindo Pharma Unit Recalls Injections
- Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling two injectable medications:
- Dexamethasone Sodium Phosphate injection USP (70,125 vials): Recalled due to failed impurities/degradation specifications.
- Eptifibatide injection (15,500 single-dose vials): Recalled due to failed impurities/degradation specifications, used to prevent blood clotting during heart attacks or chest pain.
- Recall Classification:
- Dexamethasone: Class II (potential for temporary or reversible adverse health effects).
- Eptifibatide: Class III (unlikely to cause adverse health consequences).
Importance of USFDA Compliance
India is a leading global supplier of generic medications, accounting for roughly 20% of the market share.
However, maintaining strict quality control measures is crucial to ensure patient safety and continued US market access.
This incident highlights the need for Indian pharmaceutical companies to adhere to USFDA regulations and maintain robust manufacturing practices.
Additional Considerations:
- It’s important for patients who have received the recalled medications to consult with their healthcare providers regarding alternative treatment options.
- Both Lupin and Aurobindo Pharma should take swift corrective actions to address the manufacturing issues identified by the USFDA.
- Continued vigilance by regulatory bodies like the USFDA is essential to ensure the safety and efficacy of medications available to consumers.
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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