The U.S. arm of Indian pharmaceutical giant Dr Reddy’s Laboratories is reportedly recalling more than 35,000 tubes of a skin infection cream. Called Nystatin and Triamcinolone Acetonide, the cream has been recalled by the USFDA due to failed stability specifications.
According to the U.S. health regulators Enforcement Report, Dr. Reddy’s Labs is recalling tubes of Nystatin and Triamcinolone Acetonide Cream and USP of 1,00,000 units per gram and 1mg per gram available in the American Market.
The products were taken off the market because of failed stability specifications after they were found to have failed specifications during the test parameters, which happened to be Nystatin’s composition during stability testing, the report further mentioned.
USFDA said in a statement that the voluntary ongoing recall across the nation happens to be a class II recall. It further elaborated that a class II recall is imposed during a situation in which the use of a violative product or even exposure can cause temporary or medically revocable adverse consequences on one’s health or where the chances of life-threatening and adverse health consequence are minimal.
Reportedly, the company has also sold its Active Pharmaceutical Ingredient manufacturing business unit based in Hyderabad, India to Therapiva Private Ltd, which is an emerging generic pharmaceutical company. The agreement is being worked out through a slump sale and consists of all current assets, related fixed assets, current liabilities, and the employees of the firm.
For the record, Dr Reddy’s Labs is a unified pharmaceutical company, focused on offering affordable and innovative medications for healthy living. Businesses of the firm include Global Generics, Proprietary Products, Pharmaceutical, and Active Ingredients. Its major areas of therapeutic focus include gastrointestinal, diabetology, cardiovascular, oncology, pain management and dermatology. The company operates in major markets like India, USA, Russia, Europe and CIS countries.