Glenmark Recalls Blood Pressure Medication in theUS Due to Dissolution Issues. People taking medication to manage high blood pressure in the United States should be aware of a recent recall by Glenmark Pharmaceuticals. The Indian drugmaker is recalling over 6,500 bottles of Diltiazem Hydrochloride extended-release capsules due to failing to meet quality control standards.
The US Food and Drug Administration (USFDA) announced the recall in its latest Enforcement Report. The affected medication is the Diltiazem Hydrochloride capsules, a generic drug used to treat high blood pressure and angina (chest pain).
Reason for the Recall
The recall stems from concerns about the medication's dissolution specifications. Dissolution refers to the process by which a drug breaks down and releases its active ingredients into the body. Medications, especially extended-release capsules, are designed to dissolve at a specific rate to ensure a steady release of the drug into the bloodstream for prolonged effectiveness.
According to the USFDA report, a test conducted at the 12th-month mark of a long-term stability study for the medication indicated that it failed to meet the predetermined dissolution specifications. This raises concerns that the medication might not release the drug into the body at the intended rate, potentially leading to under-treatment of the targeted condition.
Risk Associated with the Recalled Medication
The USFDA has classified this as a Class II recall. This category signifies a situation where use of the medication may cause temporary or reversible health issues, or the possibility of serious adverse effects is remote.
However, it's important to note that if you are taking the recalled medication, there could be a potential for uncontrolled high blood pressure, which can lead to serious health complications if left untreated. These complications include stroke, heart attack, heart failure, and kidney problems.
What to Do if You Have the Recalled Medication
- Check the medication bottle for the lot number and expiry date. The recall is specific to a particular lot that failed the dissolution test.
- If you have the recalled medication (refer to the USFDA website for details on identifying the affected lot), discontinue use immediately.
- Contact your doctor to discuss alternative treatment options for managing your high blood pressure.
- Do not discard the recalled medication; instead, return it to the pharmacy where you purchased it.
Glenmark's Response to the Recall
Glenmark Pharmaceuticals initiated a Class II nationwide recall of the affected Diltiazem Hydrochloride capsules on March 26, 2024. The recall involves the New Jersey-based arm of the company, Glenmark Pharmaceuticals Inc.
The company has not issued any official statement regarding the reason for the failed dissolution test or the potential health risks associated with the recalled medication.
Maintaining Blood Pressure Control and Medication Safety
If you take medication for high blood pressure, it's crucial to adhere to your doctor's instructions and attend regular check-ups to monitor your blood pressure levels. This incident highlights the importance of robust quality control measures in pharmaceutical manufacturing to ensure patient safety.
Patients are advised to stay informed about medication recalls by following trusted sources like the USFDA website. You can sign up for email notifications to receive updates on the latest drug recalls.
By working together, patients, healthcare providers, and regulatory bodies can help ensure the safety and efficacy of medications.
