Macleods Pharma USA has recalled 3,744 bottles of a combination blood pressure medication nationwide after the product failed dissolution specifications, according to an FDA enforcement report.
The voluntary recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 milligrams/10 milligrams/12.5 milligrams, in two lots: 3,528 30-count bottles (NDC 33342-246-07, lot 12251163A) and 216 90-count bottles (NDC 33342-246-10, lot 12251163B), both expiring May 31, 2027. The company, which notified consignees by letter, initiated the recall Oct. 7. The FDA classified it as Class II on Oct. 26, and the recall is ongoing.
The FDA defines a Class II recall 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 enforcement report lists failed dissolution specifications as the reason for the recall. The company did not issue a news release for the recall.
The recall follows a similar one in September, when Inventia Healthcare recalled 13,567 bottles of chlorthalidone tablets after they failed dissolution specifications.
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