In May, Dr. Reddy's Laboratories issued a voluntary recall for 13,560 bottles of its hypertension drug metoprolol succinate extended release. According to the U.S. Food and Drug Administration (FDA), the drug's inability to pass a dissolution test prompted the United States recall, which became effective on May 23, 2014. Dissolution tests are used to determine how long it takes for the active ingredient in a drug to become available for use in the body, and helps project how that ingredient will affect the body.
The Class II recall, which appeared on the FDA's website in mid-June, indicates that use of or exposure to the drug could trigger mild or temporary undesirable side effects which are medically reversible.
Only one month before the Dr. Reddy's recall, another Indian drug manufacturer, Wockhardt Ltd., was forced to recall 109,744 bottles of metoprolol succinate as well. Also like the Dr. Reddy's drug, this recall was initiated after the failure of a dissolution test.
Drug recalls are not an unusual event; however, Wockhardt was already under scrutiny for violations of manufacturing standards found in two of the company's manufacturing plants, one of which produced metoprolol succinate for the United States, being prohibited from exporting its drugs to the U.S.
Both drugs represent the latest in a rash of drug recalls elicited by quality-related concerns involving Indian companies that have tarnished the status of the industry as a supplier of inexpensive generic drugs and triggered an intensified inspection by regulators. Both drugs are less expensive versions of AstraZeneca Plc's branded drug Toprol.
Frequency of Drug Recalls in the United States
Drugs are recalled in the U.S. at an average of about one every month, for a total of 1,734 between 2004 and 2011, according to researchers at Boston's Brigham and Women's Hospital, and while the FDA has procedures in place for communicating this information, those procedures may fall short in terms of warning healthcare providers.
To keep track of the ever-growing list of recalls, visit the FDA's website for up-to-date information.
If you have a medicine that has been recalled, discuss with your healthcare provider the best course of action. Many stores have a return and refund policy governing the announcement of drug recalls.
National Dangerous Drug Lawyers
Thousands of Americans die every year because of adverse drug reactions. If you have been injured, or have lost a loved one, because of a drug reaction, contact the experienced Philadelphia product liability attorneys today to preserve your rights.