FDA Classifies 3,700 Blood Pressure Drug Bottles as Class II Recall
Updated
Updated · Prevention Magazine · Nov 3
FDA Classifies 3,700 Blood Pressure Drug Bottles as Class II Recall
3 articles · Updated · Prevention Magazine · Nov 3
Summary
3,744 bottles of generic Tribenzor were placed under a Class II recall after the FDA said the tablets may not dissolve properly, potentially reducing how well the blood pressure medicine works.
Macleods Pharma USA initiated the voluntary recall on Oct. 7, and the FDA assigned the Class II designation on Oct. 26, indicating possible temporary or medically reversible health consequences.
The affected products are 40 mg/10 mg/12.5 mg olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in 30-count lot 12251163A and 90-count lot 12251163B, both expiring May 31, 2027.
The FDA has not issued disposal guidance; patients are advised to contact the prescribing doctor before stopping the medication and to seek medical advice if they have health concerns.