Macleods Recalls 3,744 Bottles of Triple-Combination Blood Pressure Tablets Over Dissolution Failure
Macleods Pharmaceuticals is voluntarily recalling 3,744 bottles of its olmesartan medoxomil, amlodipine and hydrochlorothiazide triple-combination blood pressure tablets (40 mg/10 mg/12.5 mg) because the product failed dissolution specifications, meaning it does not release its active ingredients at the proper rate in the body and may not lower blood pressure as expected, according to the Food and Drug Administration's enforcement report. The company initiated the recall on October 7, and the FDA classified it as a Class II recall on October 26.
The recall covers 3,528 bottles in the 30-count size, National Drug Code (NDC) 33342-246-07, lot 12251163A, and 216 bottles in the 90-count size, NDC 33342-246-10, lot 12251163B. Both lots expire on May 31, 2027.
Under the FDA's classification, a Class II recall means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious health problems is low. The FDA did not issue a separate news release for this recall; its enforcement report says notification letters were sent to businesses and people who may have the medication.
The tablets are a generic version of the brand-name drug Tribenzor. Brand-name Tribenzor itself is not part of the recall, and patients taking the generic can check the NDC and lot numbers on their bottle labels to see whether their medication is included.
Published by GSM · USA (original Chinese edition)
Photo: 各式药片（资料图）。Pöllö 摄，CC BY 3.0，经 Wikimedia Commons。 / Assorted tablets (file photo). Photo by Pöllö, CC BY 3.0, via Wikimedia Commons.
