Granules recalls over 33000 bottles BP medication in US
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New Delhi: Granules India is recalling more than 33,000 bottles of a generic blood pressure lowering medication from US shelves due to manufacturing glitches, as per the US Food and Drug Administration (USFDA).
According to the latest Enforcement Report of the US health regulator, the recall targets 33,024 bottles of Metoprolol Succinate extended-release tablets in 100 count and 500 count bottles.
US-based Granules Pharmaceuticals Inc is recalling the India-produced lot due to failed dissolution specifications, PTI reported.
The product failed to meet dissolution acceptance criteria in the stability studies at the sixth month, USFDA said.
Granules initiated the nationwide Class II recall on June 24.
As per the USFDA, a Class-II recall 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.
This is the latest in a string of recalls involving Indian drugmakers.
In June, Aurobindo Pharma's U.S. unit recalled more than 4,600 bottles of its pain reliever, Acetaminophen Tablets (325 mg), in the US market due to manufacturing issues. The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain, among others.
In May, FDC Ltd also recalled 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over manufacturing issue.
Granules products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US, and UK. The Company has 10 manufacturing facilities out of which 8 are in India and 2 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
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