Dr Reddy’s Laboratories has initiated a voluntary recall of 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 USFDA website, the company has recalled Divalproex Sodium extended-release tablets as it has failed dissolution tests and Amlodipine Besylate and Atorvastatin Calcium tablets since these are close to expiry time.
“We confirm that we have initiated a voluntary recall of Divalporex. This has been done as an abundant precautionary measure, based on observations related to the products dissolution specifications,’’ the company spokesperson said. “The observations are being investigated at our end and we are confident of a satisfactory resolution at the earliest. Pending submission of the investigation report to the USFDA, we would not like to comment further at this stage,” the spokesperson added. However, the company did not specify on the expected revenue losses due to this recall.
The recall includes Divalproex Sodium extended-release tablets, USP, 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.
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).