Regulators have recalled more than 3,000 bottles of a blood pressure medication after the product failed safety testing. The three-in-one treatment contains olmesartan, amlodipine, and hydrochlorothiazide, which work together to relax blood vessels and help the body remove excess fluid. However, the tablets did not pass regulators’ dissolution tests.
That result suggests the medication may not dissolve and be absorbed by the body as intended, according to The Healthy.
The recall is classified as Class II. The FDA defines this category 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.”
The affected tablets were distributed across the United States. The recalled Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets, in the 40 mg/10 mg/12.5 mg strength, are identified as follows:
90-count bottle
NDC: 33342-246-10
Lot number: 12251163B
Expiration date: 05/31/2027
The manufacturer initiated the recall voluntarily in coordination with the FDA. Anyone who believes they have an affected bottle should contact their pharmacy for guidance.
