Last Updated on October 10, 2024 by The Health Master
Drug recall
Glenmark Pharmaceuticals, a renowned pharmaceutical company, has recently announced a drug recall of 1,200 bottles of a generic drug designed to manage high blood pressure (high BP) in the American market.
The United States Food and Drug Administration (USFDA) identified a manufacturing issue that led to the recall.
This article delves into the details of this drug recall, shedding light on the reasons behind it and the steps taken by Glenmark Pharmaceuticals in response.
Drug Recall of Trandolapril and Verapamil Hydrochloride Tablets:
Glenmark Pharmaceuticals, headquartered in New Jersey, has taken the decision to recall a specific batch of Trandolapril and Verapamil Hydrochloride extended-release tablets from the American market.
This drug recall action is in line with the USFDA’s most recent Enforcement Report, which emphasizes the potential manufacturing problem with this batch.
Manufacturing Origin and Distribution:
The affected batch of Trandolapril and Verapamil Hydrochloride tablets was manufactured at Glenmark Pharmaceuticals’ Goa plant, a subsidiary of the Mumbai-based drug firm.
Subsequently, these tablets were supplied to Glenmark Pharmaceuticals, Inc., USA.
This chain of events culminated in the USFDA’s attention being drawn to a potential concern, necessitating the recall.
Reason for Recall:
The recall has been initiated due to the identification of a “Subpotent” attribute in the affected bottles of Trandolapril and Verapamil Hydrochloride tablets.
This essentially means that the potency or effectiveness of the tablets may not meet the required standards, raising concerns about their ability to effectively manage high blood pressure as intended.
Initiation of the Drug Recall:
Glenmark Pharmaceuticals Inc., the subsidiary responsible for operations in the United States, has taken proactive measures to address the manufacturing concern.
They initiated a Class III recall across the nation on August 14 of the current year.
A Class III recall is implemented when a defective product is used or exposed to but no significant negative health effects are anticipated, according to the USFDA.
USFDA’s Classification and Overview:
The USFDA’s classification of the recall as Class III highlights that while there is a manufacturing concern associated with the Trandolapril and Verapamil Hydrochloride tablets, the likelihood of this issue causing serious health consequences is relatively low.
This classification emphasizes that the recall is a precautionary measure aimed at ensuring the consistent quality and effectiveness of pharmaceutical products on the market.
Conclusion:
In the interest of public health and safety, Glenmark Pharmaceuticals’ decision to voluntarily recall the affected batch of Trandolapril and Verapamil Hydrochloride tablets demonstrates their commitment to maintaining the highest standards of pharmaceutical quality.
While the recall has been necessitated by a manufacturing concern, the proactive approach taken by Glenmark Pharmaceuticals and the USFDA’s classification reassure consumers that their health remains a top priority.
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