Dr Reddy's Laboratories Ltd has volunteered to withdraw
13,560 bottles of metoprolol succinate extended release tablets from the United
States following the failure of dissolution tests, said the US Food and Drug
The USFDA website said, "Failed dissolution specifications:
failure of dissolution test observed at 18-month time point," as the reason for
The drug is used to prevent chest pain, medically known as angina, and improve
survival rates after a heart attack by controlling blood pressure.
Metoprolol succinate extended release is a cheaper generic
form of Toprol XL.
Dissolution tests are aimed at calculating the time taken
for an active ingredient in a drug to release into the body and also assessing
the drug's performance inside the body.
Wockhardt Ltd also withdrew 109,744 bottles of the said drug
a month ago due to the same reason.
The withdrawal of this type is classified by the FDA as
Class II, which indicates use of or exposure to the withdrawn products may
cause temporary or medically reversible adverse health consequences.
Dr. Reddy's had earlier this year withdrawn about 58,656 bottles of
lansoprazole, a heartburn drug, from the United States
due to a microbial contamination.
A series of drug recalls have happened in the recent times due
to quality issues involving Indian companies that have damaged the reputation
of the industry as a cheap generic drug supplier thereby inviting stricter drug
specifications from the regulators.