The US Food and Drug Administration designated the withdrawal of more than 3,700 bottles of Tribenzor as a Class II recall on Oct 26. This classification reflects a low likelihood of serious harm, warning only of potentially temporary or medically reversible consequences if taken. The Health Sciences Authority confirmed that none of the affected lots produced by Macleods Pharmaceuticals are marketed through official channels in Singapore. Patients using the medication overseas are generally permitted to finish their supply unless instructed otherwise by their physicians.
Key points
Singapore's medication supply remains completely unaffected because the recalled product…: Singapore's medication supply remains completely unaffected because the recalled product lots were never distributed locally.
The US Food and Drug Administration assigned a Class II recall status indicating serious…: The US Food and Drug Administration assigned a Class II recall status indicating serious adverse health consequences remain remote.
The impacted medication lots bear an expiration date of May 31, 2027.: The impacted medication lots bear an expiration date of May 31, 2027.
Sources checked by our analysis pipeline: 1
- HSA said the US recall of Macleods’ blood pressure drug does not affect Singapore because the affected products are not sold here.
- The recall covers Tribenzor tablets from two lots after “failed dissolution specifications” raised concerns the medicine may not work properly.
- The US FDA made it a Class II recall, meaning possible “temporary or medically reversible adverse health consequences”, but serious harm is unlikely.
AI generated
SINGAPORE - A recent recall which resulted in more than 3,700 bottles of blood pressure medicine taken off the shelves in the United States does not affect consumers here, said the Health Sciences Authority (HSA).
Macleods Pharmaceuticals announced in early October that it is recalling certain batches of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, sold under the brand name Tribenzor as a medication for hypertension, or high blood pressure.
“The affected products manufactured by Macleods Pharmaceuticals are not marketed in Singapore,” said HSA in response to queries from The Straits Times.
“Hence, the product recall in the US does not affect medicines supplied through authorised local distribution channels here.”
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