Last Updated on September 30, 2024 by The Health Master
Drug recall
Drug recall by Aurobindo Pharma, Glenmark Pharmaceuticals, FDC Ltd due to Quality Issues.
Aurobindo Drug Recall: Pain Medication
Hyderabad-based drug giant Aurobindo Pharma recently initiated a voluntary drug recall of 240 bottles of its Healthy Living Acetaminophen, Aspirin (NSAID), and caffeine tablets in the United States.
The drug recall was prompted by a significant labeling error, where the manufacturer’s label, including essential drug facts information, was missing from some bottles.
The US Food and Drug Administration (USFDA) classified this drug recall as Class I, the most serious type, indicating that the defective product could potentially lead to serious health problems.
Glenmark Drug Recall: of Indomethacin Capsules
Another Indian pharmaceutical company, Glenmark Pharmaceuticals, also faced a drug recall in the US.
Its US-based subsidiary recalled 2,404 bottles of Indomethacin Extended-Release Capsules produced at a plant in Madhya Pradesh.
The reason for the drug recall was “Failed Dissolution Specifications,” suggesting that the capsules might not dissolve properly in the body, potentially affecting their effectiveness.
The USFDA categorized this drug recall as Class II, indicating that the use of the defective product could cause temporary or reversible health issues.
FDC Drug Recall: Timolol Maleate Ophthalmic Solution
Maharashtra-based FDC Ltd was also involved in a drug recall due to a packaging defect.
The company recalled 1,76,784 bottles of Timolol Maleate Ophthalmic Solution USP.
The issue arose when patients found that the cap’s spike was lodged in the nozzle, making it difficult or impossible to extract the solution.
Similar to Glenmark’s drug recall, the USFDA classified this drug recall as Class II.
India’s Dominance in US Pharmaceutical Market
It’s worth noting that India has a substantial presence in the US pharmaceutical market.
The country boasts the highest number of USFDA-compliant pharmaceutical plants outside of the United States.
This dominance underscores India’s role as a major supplier of generic medications to 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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