Granules India Recalls 33,000 Bottles of Blood Pressure Medication in US Due to Manufacturing Defects
核心洞察
Granules India is recalling over 33,000 bottles of Metoprolol Succinate extended-release tablets from the US market due to failed dissolution specifications during stability studies.
The US FDA (搜索) classified this as a Class II recall, indicating potential for temporary or medically reversible health consequences with minimal likelihood of serious adverse outcomes.
This recall represents the latest in a series of quality control issues affecting Indian pharmaceutical manufacturers in the US market.
Granules India is recalling more than 33,000 bottles of a generic blood pressure medication from US shelves due to manufacturing defects, according to the US Food and Drug Administration (USFDA). The Hyderabad-based pharmaceutical company initiated the nationwide recall on June 24 after the product failed to meet critical quality specifications.
Recall Details and Scope
The recall targets 33,024 bottles of Metoprolol Succinate extended-release tablets, available in both 100 count and 500 count bottles. US-based Granules Pharmaceuticals Inc is recalling the India-produced lot due to failed dissolution specifications, as reported in the USFDA's latest Enforcement Report.
The product failed to meet dissolution acceptance criteria in stability studies at the sixth month, prompting the regulatory action. The USFDA classified this as a Class II recall, which is initiated when the use of or exposure to a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Industry Pattern of Quality Issues
This recall represents the latest in a string of recalls involving Indian drugmakers in the US market. In June, Aurobindo Pharma's US unit recalled more than 4,600 bottles of Acetaminophen Tablets (325 mg) due to manufacturing issues. The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain.
In May, FDC Ltd (搜索) recalled 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over manufacturing issues, highlighting ongoing quality control challenges facing Indian pharmaceutical manufacturers.
Company Profile and Global Reach
Granules products are distributed to over 300 customers in regulated and semi-regulated markets, with a global presence extending to over 80 countries and offices across India, the US, and UK. The company operates 10 manufacturing facilities, with 8 located in India and 2 in the USA.
The company maintains regulatory approvals from multiple international agencies including US FDA (搜索), EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL, demonstrating its commitment to meeting global pharmaceutical standards despite the current quality control setback.
Market Impact
Following the recall announcement, shares of Granules India were trading 0.54 percent down at Rs 479.10 apiece on the Bombay Stock Exchange, reflecting investor concerns about the potential impact on the company's US operations and reputation in regulated markets.