A drug company is recalling more than 10,000 bottles of a high blood pressure and heart drug due to failed specifications, according to a notice published by the Food and Drug Administration this week.
New Jersey-based Ascend Laboratories is recalling combined amlodipine and olmesartan medoxomil tablets with a dose range of 10 mg/40 mg, the notice said.
The company said 11,424 bottles are being recalled, with a lot number of 25120696. The product’s expiration date is Dec. 31, 2026.
The reason for the recall is “out of specification due to dissolution,” the report said. The FDA has defined an out-of-specification (OOS) result as when a drug impurity is found that falls “outside the specifications or acceptance criteria established in drug applications.”…