Drug major Sun Pharma has recalled certain lots of Nimodine capsules, a drug indicated to treat brain haemorrhage, in the US market due to crystal formation.
As per the information available on the US Food and Drug Administration website, the company is recalling the Nimodine capsules, 30 mg due to "crystallisation".
The recall falls under Class II category, and it is done in a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
As per the USFDA, 46,387 cartons of the drug have been distributed in the US market. The recall has been initiated voluntarily by the drug maker and the same was intimated to the drug regulator through a letter on May 21.
Comments from the company could not be obtained immediately.
Last year, the Mumbai-based firm had recalled one lot of the drug as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution.
Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage (bleeding in the brain).
Shares of Sun Pharma on Friday closed at Rs 1,080.25 apiece on the BSE, down 3.35 per cent down from the previous close.