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Time of India

Granules India recalls 33,000 bottles of blood lowering medication in US

Granules India is recalling over 33,000 bottles of Metoprolol Succinate, a generic blood pressure medication, in the US due to manufacturing issues. The USFDA reported that the India-produced lot failed to meet dissolution specifications during stability studies. This Class II recall, initiated on June 24, indicates a potential for temporary or medically reversible health consequences. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads 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 Granules Pharmaceuticals Inc is recalling the India-produced lot due to failed dissolution specifications , it product failed to meet dissolution acceptance criteria in the stability studies at the sixth month, USFDA initiated the nationwide Class II recall on June 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 of Granules India were trading 0.54 per cent down at Rs 479.10 apiece on BSE.