Dr Reddy's Lab is recalling two drugs used to treat seizure and hypertension from the US market. The company claimed that this is part of its precautionary measures and investigations have been initiated on the recall.
According to The Financial Express report, the recall includes Divalproex Sodium extended-release tablets, 250 mg of 100 count (7,479 units) and 500 count bottles (2,544) units on the ground of "failed dissolution specifications, exceeded specification at the 9-hour time point". The drug is being recalled under the "class-II" classification. This classification is a situation in which the use of or exposure to a violative product may cause a temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote. Both the drugs are manufactured at the company's Bachupally facility in Hyderabad. The company had launched Divalproex in US in August, 2013 and Amlodipine Besylate and Atorvastatin Calcium tablets were launched in June last year.
Similarly, the company has initiated the recall of some lots of Amlodipine Besylate and Atorvastatin Calcium tablets of various strengths in 30-count and 90- count bottles. The reason for recall was cited as subpotent. The recall of these tablets is being made under "class-III" classification which means a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Amlodipine Besylate and Atorvastatin Calcium tablets are used to treat high blood pressure (hypertension) or chest pain (angina).