1. Dr Reddy’s initiates recall of dementia capsules from US market

Dr Reddy’s initiates recall of dementia capsules from US market

The USFDA said the capsules had failed some of the specifications while dissolving

By: | Hyderabad | Published: August 21, 2015 12:27 AM

Dr Reddy’s Laboratories has initiated voluntary recall of Rivastigmine Tartrate capsules of 1.5 mg strength from the US market, following ‘failed dissolution specifications’. Rivastigmine Tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type or Parkinson’s disease.

The USFDA said the capsules had failed some of the specifications while dissolving, which is part of test procedures for new drugs. The regulator said  “out-of-specification results for dissolution found”.

A total of 60 bottles of 2,952 units have been recalled on the direction of the US Food and Drug Administration (USFDA).

According to a notification issued by the USFDA, the batch was manufactured at DRL’s Bachupally unit and the recall was initiated under “Class II” classification.

A 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.

Recently, the company had initiated a nationwide voluntary recall of two drugs  — Divalproex Sodium extended release tablets and Amlodipine Besylate atorvastatin calcium tablets.

Last year also, the company had initiated voluntary recalls twice, including that of heartburn drug Lansoprazole for microbial contamination. Incidentally, both were manufactured at the Bachupally plant.

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