Dr Reddy's Laboratories recalls Rivastigmine Tartrate capsules from US market
20 Aug 2015
Dr Reddy's Laboratories is recalling its mild dementia treatment drug Rivastigmine Tartrate capsules of 1.5 mg strength from the US market due to 'Failed Dissolution Specifications'.
Rivastigmine Tartrate capsules are intended for the treatment of mild to moderate dementia of the Alzheimer's type or Parkinson's disease.
Dr Reddy's will recall 60 bottles of 2,952 units that were manufactured at its Bachupally unit near Hyderabad.
The US Food and Drug Administration has initiated the recall under "Class II" classification, which means that use or exposure may cause temporary or medically reversible health consequences.
A failed dissolution classification is a test to check the amount of time it takes the active ingredient to release into the body.
This is the latest in a string of drug recalls and manufacturing quality-related issues involving Indian companies that have hurt the reputation of the industry as a supplier of cheap generic drugs, and led to increased scrutiny from regulators.
In March last year, Dr. Reddy's recalled 58,656 bottles of the heartburn drug lansoprazole in the US due to microbial contamination and three months later recalled 13,560 bottles of its high blood pressure drug metoprolol succinate in the US after it failed a dissolution test.
