Dr Reddy’s Lab recalls 13,560 bottles of heart drug in US
21 Jun 2014
Dr Reddy`s Laboratories Ltd is recalling 13,560 bottles of its high blood pressure drug metoprolol succinate in the United States after it failed a dissolution test - a measure to check the amount of time it takes the active ingredient to release into the body - the US Food and Drug Administration said.
Metoprolol succinate extended release is a cheaper generic form of AstraZeneca Plc`s Toprol XL and the dissolution test was meant to help predict the drug's performance inside the body.
Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is used to prevent angina (chest pain) and to improve survival after a heart attack.
Another Indian drug maker Wockhardt Ltd also recalled 109,744 bottles of the same drug last month on the same reason.
The recall, which was voluntarily started by Dr Reddy`s on 23 May 2014, was posted on the FDA website on Thursday.
The FDA classifies the recall as Class II, which means that use or exposure may cause temporary or medically reversible health consequences.
Angina, also called angina pectoris, is the medical term used to describe chest pain or a feeling of tightness, heaviness and discomfort in the chest as a result of inadequate blood oxygen supply to the heart muscle.
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, Dr. Reddy's recalled 58,656 bottles of the heartburn drug lansoprazole due to microbial contamination. Indian drug makers have been hit by numerous quality issues this year which has prompted increased scrutiny from regulators.
