Last Updated on October 15, 2024 by The Health Master
Drug recall
Glenmark Pharmaceuticals, a leading Indian drugmaker, has announced voluntary drug recall for two of its products in the United States due to manufacturing defects.
The drug recall, initiated by the company’s US subsidiary, Glenmark Pharmaceuticals Inc., USA, were prompted by issues related to the delivery systems and packaging of the affected products.
Ryaltris Nasal Spray Recall
The first product recalled is Ryaltris Nasal Spray, a combination medication used to treat allergic rhinitis (hay fever).
A total of 45,504 bottles of the affected lot were recalled due to a “defective delivery system.”
The US Food and Drug Administration (USFDA) identified that the dip tube in the spray bottles was clogged, preventing the medication from being dispensed correctly.
Glenmark initiated a nationwide Class II drug recall for Ryaltris on September 24, 2024.
A Class II drug recall is issued when the use of a product could potentially lead to temporary or reversible adverse health consequences.
Ciclopirox Gel Recall
In addition to the Ryaltris recall, Glenmark also announced a drug recall for 11,568 tubes of Ciclopirox Gel, a generic medication used to treat certain fungal skin infections.
The drug recall was triggered by complaints of broken tubes at the seal.
he company initiated a Class III recall for Ciclopirox Gel on September 30.
A Class III recall is issued when the use of a product is unlikely to cause any adverse health consequences.
Impact on India’s Pharmaceutical Industry
These drug recalls highlight the importance of quality control and manufacturing standards in the pharmaceutical industry.
India, which is the world’s largest supplier of generic medicines, has a significant number of USFDA-compliant companies.
The country’s pharmaceutical exports reach over 200 countries, with major markets including Japan, Australia, West Europe, and the United States.
While these drug recalls may raise concerns about the quality of Indian-manufactured drugs, it is important to note that such incidents are relatively rare.
The vast majority of Indian pharmaceutical products meet the highest international standards.
In conclusion, Glenmark’s voluntary drug recall underscore the company’s commitment to patient safety and regulatory compliance.
As the pharmaceutical industry continues to grow, it is essential for manufacturers to prioritize quality control and adhere to stringent manufacturing practices to ensure the safety and efficacy of their products.
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.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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