India's Dr Reddy's Laboratories is recalling 13,560 bottles of its high blood pressure drug, metoprolol succinate -- a generic form of AstraZeneca Plc's Toprol XL -- in the United States after the drug failed a dissolution test.
In May, Wockhardt also recalled 109,744 bottles of its generic version of AstraZeneca's Toprol XL in the U.S. for the same reason.
A failed dissolution test means a tablet did not disintegrate in the required period of time. Active absorption of oral dosage forms depends on adequate release of the API from the product, so dissolution plays a pivotal role in this. The Dr Reddy's recall, like the Wockhardt recall, was classified by the FDA as Class II -- meaning use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
Read the Reuters press release