Failed Dissolution Test Prompts Dr Reddy’s to Recall over 13,000 Bottles of High Blood Pressure Drugs

Dr-Reddy’s-Recall- 13,000-Bottles-of-High-Blood-Pressure-DrugsAccording to the U.S. Food and Drug Administration (FDA), Dr Reddy’s Laboratories Ltd is recalling 13,560 bottles of metoprolol succinate, a high blood pressure medication. The recall was issued after the drug failed a dissolution test, the FDA said. The recalled drug is a generic version of Toprol XL, manufactured by AstraZeneca Plc.

This recall is the latest in a series of events leading regulators to investigate the quality of generics, specifically those manufactured overseas. Last month, Wockhardt Ltd recalled 109,744 bottles of metoprolol succinate for the same reason.

Companies based in India have been of particular concern, according to The New York Times. Wockhardt is banned from exporting drugs to the US that were manufactured in two Indian facilities where regulators expressed serious quality concerns.

The FDA classified this recall as Class II, meaning that exposure to the drugs can lead to temporary or medically reversible adverse events. The agency gave the same designation to Wockhardt’s recall.

Dr Reddy’s issued another recent recall in March, Reuters reports. The company recalled about 58,656 bottles of lansoprazole, a heartburn drug, due to a microbial contamination.

Dissolution tests are used to determine how long it takes an active ingredient in a drug to release into the body, and help predict its performance.

Concerns about generic metoprolol succinate sprouted in 2012, when a cardiologist at the Cleveland Clinic told the FDA that he noticed symptoms such as chest pain with the generics. These symptoms disappeared once he switched to the brand name, The New York Times reports.

Generic manufacturers have had continuous problems trying to replicate Toprol XL. The brand name drug lost its patient in 2006. Two years later, Novartis division Sandoz recalled its generic version. The same occurred in 2009 with the manufacturer Ethex. According to The New York Times, drug-industry experts attribute the problem to the fact that the drug is an extended-release tablet. Brand-name manufacturers have patents on the active ingredient of a drug, as well as the way it is released. This means that generic manufactures have to figure out their own methods of extended release even if the patent on the active ingredient is up for grabs.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.