Dr. Reddy’s Recalls Hypertension Drug
About the Hypertension Drug Recall
According to Reuters, the recall was issued after the drug failed a dissolution test.
The drug, metoprolol succinate extended release, is a generic form of AstraZeneca’s Toprol XL that is manufactured in India. Last month, another pharmaceutical firm, Wockhardt Ltd, recalled 109,744 bottles of the compound for the same reason.
Dissolution tests are used to determine how long it takes for the drug’s active ingredient to release into the body. This helps to predict how the drug will act once taken.
The U.S. Food and Drug Administration (FDA) has classified the recall as a Class II recall, meaning that use of the product may cause temporary adverse events.
String of Drug Recalls in India
Indian pharmaceutical companies have been at the center of a number of recalls recently with many of the recalls being linked to quality concerns.
This has damaged the nation’s reputation as a manufacturer and supplier of generic drugs and has resulted in scrutiny from regulation agencies.
In March, Dr. Reddy’s recalled roughly 58,500 bottles of the heartburn drug lansoprazole following concerns of microbial contamination.
Potential Adverse Events Linked to the Drug
The FDA has received reports of the following adverse events occurring in patients taking metoprolol succinate:
- Chest pain
- Atrial fibrillation
- Heart attack