Last Updated on October 10, 2024 by The Health Master
Drug recall
This article highlights recent drug recall initiated by two prominent Indian pharmaceutical companies, Cipla and Glenmark, in the US market due to manufacturing issues.
Cipla Drug Recall
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
- Reason for Drug Recall: “Short fill” – inadequate medication volume in the product.
- Affected Product: 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution manufactured at Cipla’s Indore SEZ plant.
- Potential Health Risks: USFDA classifies this as a Class II drug recall, indicating a low probability of serious adverse health consequences, but potential for temporary or reversible issues.
- Drug Recall Initiated: March 26, 2024, by Cipla USA.
Glenmark Drug Recall
Diltiazem Hydrochloride Extended-Release Capsules
- Reason for Drug Recall: “Failed dissolution specifications” – medication may not dissolve properly in the body.
- Affected Product: 3,264 bottles of Diltiazem Hydrochloride extended-release capsules for high blood pressure.
- Potential Health Risks: Similar to Cipla’s drug recall, classified as Class II by USFDA with a low risk of serious health issues.
- Drug Recall Initiated: April 17, 2024, by Glenmark Pharmaceuticals Inc., USA.
Impact on Indian Pharmaceutical Industry Reputation
India is a global leader in generic drug manufacturing, supplying nearly 20% of the world’s needs.
These drug recalls raise concerns about quality control measures within Indian pharmaceutical companies.
While both drug recalls involve Class II issues, maintaining stringent manufacturing standards is crucial for the industry’s long-term reputation and market share.
Looking Forward
These recent drug recalls highlight the importance of robust quality control procedures within Indian pharmaceutical companies.
Maintaining compliance with international regulatory standards, such as those set by the USFDA, is essential to ensure patient safety and build trust in the global market.
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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