A voluntary recall of Rivastigmine Tartrate Capsules of 1.5 mg strength from the US market has been initiated by Dr Reddy's Laboratories (DRL), following 'Failed Dissolution Specifications'.
A total of 60 bottles of 2952 units are recalled on the direction of US Food and Drug Administration (USFDA). According to a notification issued by the agency, the batch was manufactured at DRL's Ltd, Bachupally unit and the recall was initiated under "Class II" classification. Rivastigmine Tartrate Capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type or Parkinson's disease.
According to the US health regulator, Class II recall is 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.