Blood Pressure Drug Recall: 3,744 Bottles Pulled Nationwide After Tablets Fail Dissolution Tests
In its October 26 enforcement report, the U.S. Food and Drug Administration (FDA) classified a recall by Macleods Pharma USA of a three-in-one blood pressure medication as Class II. The recall covers 3,744 bottles and was prompted by failed dissolution specifications: dissolution testing measures how a tablet breaks down and releases its active ingredients, and a failure can mean the drug may not be absorbed as intended. A Class II recall means use of the product may cause temporary, medically reversible health consequences, while the probability of serious harm is remote.
The medication is a combination tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide, in the 40 mg/10 mg/12.5 mg strength, used to treat high blood pressure: olmesartan and amlodipine help relax blood vessels, and hydrochlorothiazide helps the body remove excess fluid.
Two lots are affected: 30-count bottles, lot 12251163A, National Drug Code (NDC) 33342-246-07; and 90-count bottles, lot 12251163B, NDC 33342-246-10. Both lots expire on May 31, 2027, and the tablets were distributed nationwide. The FDA enforcement report lists the action under recall number D-0077-2027.
According to the enforcement report, Macleods Pharma USA initiated the voluntary recall on October 7, and the FDA issued the Class II classification on October 26. The company is headquartered in Princeton, New Jersey, and the tablets were manufactured for it in India.
Patients who take this combination medication can check the lot number and NDC on their prescription packaging against the details above; where a lot number does not appear on the outer packaging, the dispensing pharmacy can confirm whether a supply is affected. (Source: FDA enforcement report)
Source: GSM · USA (original Chinese edition)
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