Dr. Reddy's Recalls Hypertension Drug in the U.S.Jun 24, 2014
Dr. Reddy's Laboratories Ltd. just issued a recall of 13,560 bottles of its high blood pressure drug, metoprolol succinate, in the United States, according to the U.S. Food and Drug Administration (FDA). The drug failed a dissolution test.
Metoprolol succinate extended release is the generic form of AstraZeneca Plc's Toprol XL. In fact, Wockhardt Ltd. recalled 109,744 bottles of its generic version of this medication for the same reason last month, according to Reuters.
Dissolution tests are typically conducted to determine how long it takes for a drug’s active ingredient to be released into the body, and to also help predict how the drug performs within the body, wrote Reuters.
Both the Dr. Reddy’s and the Wokhardt recalls were deemed Class II recalls by the FDA, which means that use or exposure to these products make lead to a temporary or medically reversible adverse health consequence.
This is just the latest in a number of drug recalls and manufacturing quality-related issues that have involved companies based in India, according to Reuters. For example, this March, Dr. Reddy’s recalled some 58,656 bottles of lansoprazole, a heartburn medication, in the United States due to a microbial contamination. These types of activities have damaged the industry’s reputation as a supplier of more cost-effective generic drugs and have resulted in increased regulator scrutiny.