Indian Drug Manufacturer Issues U.S. Recall of Dementia Medication

Indian Drug Manufacturer Issues U.S. Recall of Dementia Medication
Image: NCCC
August 20, 2015

Dr. Reddy's Laboratories is issuing a recall for dementia medication due to safety concerns.

The Hyderabad, India-based pharmaceutical manufacturer made the decision this week to voluntarily recall a lot of Rivastigmine Tartrate Capsules. The recall affects 1.5 mg-strength tablets and is only applicable to the United States market.

A total of 60 bottles containing 2952 pills are believed to be affected. The tablets are guilty of "failed dissolution specifications", a class II recall, according to the U.S. Food and Drug Administration's (FDA). The faulty batch was manufactured at Dr. Reddy's Bachupally plant.

Rivastigmine Tartrate Capsules are designed to treat dementia in patients suffering from Alzheimer's or Parkinson's disease.

According to the FDA, a Class II recall is a situation in which the use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.