Granules Recalls Blood Pressure Drug in US
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Granules India recalls 33,000 bottles of Metoprolol Succinate due to manufacturing issues. The US FDA initiated a Class II recall.
New Delhi, Jul 9 (PTI) Drug firm Granules India is recalling over 33,000 bottles of a generic blood pressure lowering medication in the US due to manufacturing issues, according to the US Food and Drug Administration.
The Hyderabad-based drug maker is recalling 33,024 bottles of Metoprolol Succinate extended-release tablets in 100 count and 500 count bottles, the US health regulator said in its latest Enforcement Report.
US-based Granules Pharmaceuticals Inc is recalling the India-produced lot due to failed dissolution specifications, it added.
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.
Shares of Granules India were trading 0.54 per cent down at Rs 479.10 apiece on BSE.
The Hyderabad-based drug maker is recalling 33,024 bottles of Metoprolol Succinate extended-release tablets in 100 count and 500 count bottles, the US health regulator said in its latest Enforcement Report.
US-based Granules Pharmaceuticals Inc is recalling the India-produced lot due to failed dissolution specifications, it added.
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.
Shares of Granules India were trading 0.54 per cent down at Rs 479.10 apiece on BSE.
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