A drug company is recalling more than 10,000 bottles of a high blood pressure and heart drug because of failed specifications, according to a notice published by the Food and Drug Administration.
New Jersey-based Ascend Laboratories is recalling combined amlodipine and olmesartan medoxomil tablets with a dose range of 10 milligrams/40 milligrams, 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.
Alkem Laboratories Ltd., an Indian-based company that has had several of its medications recalled this year, manufactured the medication. It was distributed by Ascend Laboratories across the United States, the notice said.
Other details about the recall were not provided, including what consumers should do with the recalled medication. No news release was issued by the recalling firm.
The FDA classified the recall as class II, the second-highest on a three-tier list, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Class II and class III recalls mean that “consumers can generally continue taking the medicine unless the recalling company provides other instructions.”
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” the agency advises. “Talk to your doctor or pharmacist if you have questions or concerns about your medicine.”
The recall was initiated on Oct. 6, and the FDA issued its classification for the product on Oct. 16. The recall notice was uploaded on the FDA’s database for the week of Oct. 30.
Combined olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in 40 milligram/10 milligram/12.5 milligram doses were recalled in a separate action, the FDA said. The drug was manufactured by Macleods Pharmaceuticals Ltd., based in India, and was made for Macleods Pharma USA, Inc., which issued the recall.
A similar reason was listed for that recall: “failed dissolution specifications,” the notice said.
The company said 3,528 30-count bottles, which have a lot number of 12251163A and expiration date of May 31, 2027, are being recalled. It also said that 216 90-count bottles, with a lot number of 12251163B and the same expiration date, were also subject to the recall.
The recall was initiated on Oct. 7, and the FDA classified it as Class II on Oct. 26.
According to the Mayo Clinic, amlodipine and olmesartan is a combination used to treat high blood pressure, also known as hypertension, which can help lower the workload of the heart. Lowering blood pressure can reduce the risk of heart attack or stroke, the clinic says.
Hydrochlorothiazide is also used to lower blood pressure, to treat fluid retention, and as a diuretic, according to the Mayo Clinic.
