India’s Dr. Reddy’s Laboratories has announced it is voluntarily recalling 13,560 bottles of hypertension drug metoprolol succinate in the U.S., due to the high blood pressure drug failing a dissolution test.
Dissolution tests are conducted to check the time it takes for the active ingredient in a drug to release into the body, and help predict how the drug performs inside the body.
According to the Food and Drug Administration (FDA), the recall of Dr. Reddy’s metoprolol succinate extended release tablets, USP 25 mg. 100-count bottle, is a Class II recall. This means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
Metoprolol succinate extended release is a less expensive generic form of AstraZeneca’s Toprol XL.
This recall comes on the heels of Wockhardt Ltd.’s recall of 109,744 bottles of the same drug last month for the same reason. Both companies’ recalls were classified by the FDA as Class II.
In March, Dr. Reddy’s recalled about 58,656 bottles of the heartburn drug lansoprazole in the U.S. because of a microbial contamination.
Dr. Reddy’s began to voluntarily recall metoprolol succinate on May 23, 2014; the recall was posted on the FDA website on June 19, 2014.
An FDA spokesman told Healthline, “The recent Wockhardt and Dr. Reddy’s metoprolol succinate recalls are independent isolated events that the companies are voluntarily addressing. These don’t reflect the entire product lines, but the specific lots identified in each recall event. These recalls are the result of routine tests that brand and generic companies perform as part of their quality management.”
The FDA spokesman added, “This is a Class II recall, which means that it is at the pharmacy level, so patients can still take the product; however, if they are concerned they can speak with the doctor for advice and option.”
Healthline contacted a Dr. Reddy’s spokesperson in India, who said the company has put a corrective action plan in place.