Blood Pressure Medication Recalled Due To Quality Issues

FDA Issues Recall For Blood Pressure Treatment

Patients utilizing prescription medication to manage high blood pressure are being urged to review their current supplies following a nationwide recall. The Food and Drug Administration has announced that specific lots of a combination treatment consisting of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide have been pulled from the market. The recall was initiated by Macleods Pharma USA after the medication failed to meet federal quality standards.

The specific issue identified during testing was a failure to meet dissolution specifications. This means the tablets did not dissolve as required, which can impact how the medication is absorbed and utilized by the body. The recall affects two specific lots of the medication, both of which carry an expiration date of May 31, 2027. The first affected lot is 12251163A, which includes 3,528 bottles containing 30 tablets each. The second affected lot is 12251163B, which consists of 216 bottles containing 90 tablets each.

Understanding The Medication And Recall Class

The recalled product is a combination of three different types of medications used to treat hypertension. Olmesartan serves as an angiotensin II receptor blocker, Amlodipine acts as a calcium channel blocker, and Hydrochlorothiazide is a diuretic. These components can be used individually or in combination to help lower blood pressure and reduce the risk of cardiovascular complications.

To help patients identify if their medication is part of the recall, the FDA provided National Drug Codes (NDC). The 30-count bottles are listed under NDC 33342-246-07, while the 90-count bottles are listed under NDC 33342-246-10. Patients are encouraged to check their prescription labels for these specific codes and lot numbers to ensure they are not using a violative product.

The agency has categorized this action as a Class II recall. According to the FDA, a Class II designation is used for situations where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. In such cases, the probability of serious adverse health consequences is considered remote. The recall process began on October 7, and the FDA officially classified the recall on October 26.

Broader Trends In Medication Recalls

This incident is not an isolated case of blood pressure medication being recalled for quality failures. In a separate instance in September, Inventia Healthcare Limited recalled more than 13,500 bottles of chlorthalidone tablets. Similar to the Macleods Pharma recall, the chlorthalidone tablets were pulled because they failed dissolution specifications. That specific recall involved 25mg doses distributed in 100-count bottles with batch number RISA24002 and an expiration date of April 2027.

Chlorthalidone is a diuretic, often referred to as a water pill, used not only for high blood pressure but also to treat fluid retention associated with kidney disease, severe liver disease, or congestive heart failure. The FDA classified the chlorthalidone recall as a Class II action as well, with the initial notice issued on September 3 and the classification finalized on September 17. This highlights a pattern of quality control issues regarding how these specific types of tablets dissolve during testing.

Furthermore, other manufacturers have faced similar challenges. In June, Rising Pharma Holdings also recalled chlorthalidone medications due to failed dissolution specifications. These recurring issues highlight the importance of strict adherence to federal quality standards to ensure that medications dissolve correctly and provide the intended therapeutic effect for patients managing chronic conditions like hypertension. Patients are advised to consult their healthcare providers or pharmacists if they find they are using any of the affected lots to determine the best course of action for their treatment and to ensure their blood pressure remains properly managed.