Metformin extended release 500 mg recall

Important Safety Recall Notice

Dear valued customer,

We would like to bring to your attention a voluntary recall of Metformin Extended Release 500 mg tablets. This recall has been initiated due to deviations detected in the level of a potential carcinogen called N-Nitrosodimethylamine (NDMA).

What is Metformin?

Metformin is a medication commonly used to treat type 2 diabetes. It helps to control blood sugar levels by reducing glucose production in the liver and improving the body's response to insulin.

Why is there a recall?

Recent tests have shown that certain batches of Metformin Extended Release 500 mg tablets may contain higher levels of NDMA than the acceptable limit set by the U.S. Food and Drug Administration (FDA). NDMA is classified as a probable human carcinogen, which means it has the potential to cause cancer.

Your safety is our priority

As a responsible company, we have taken immediate action to recall the affected batches of Metformin Extended Release 500 mg tablets. We are working closely with the FDA to investigate and resolve this matter as quickly as possible to ensure the safety and well-being of our customers.

What should you do?

If you are currently taking Metformin Extended Release 500 mg tablets, we advise you to contact your healthcare provider immediately. They will be able to guide you on the next steps to take, including the possibility of switching to an alternative medication.

Our commitment to quality

We apologize for any inconvenience or concern this recall may cause. Please be assured that we are fully committed to ensuring the highest quality standards for our products. Your safety and trust are of utmost importance to us.

"At [Company Name], your health and well-being drive our commitment to excellence. We will continue to be transparent and take all necessary actions to address this issue effectively."

Should you have any further questions or concerns, please do not hesitate to contact our customer service department at [phone number] or by email at [email address]. We will be more than happy to assist you in any way we can.

Thank you for your understanding and cooperation.

Sincerely,

[Your Company Name]

Benefits of Metformin

1. Effective in managing diabetes

Metformin has been widely recognized as an effective medication for managing diabetes. It helps lower blood sugar levels by reducing the amount of glucose produced by the liver and improving the body's sensitivity to insulin. This can help individuals with type 2 diabetes better control their blood sugar levels and reduce the risk of complications associated with high blood sugar.

2. Weight management

In addition to its blood sugar-lowering effects, metformin has also been found to be beneficial for weight management in individuals with diabetes. It helps reduce appetite and promotes weight loss, which can be particularly beneficial for those struggling with obesity or trying to achieve a healthy weight. By helping individuals maintain a healthier body weight, metformin can improve overall health and reduce the risk of other related conditions.

3. Lower risk of cardiovascular disease

Studies have shown that metformin may have protective effects on the cardiovascular system. It has been associated with a reduced risk of heart disease, stroke, and other cardiovascular events in individuals with diabetes. This is thought to be due to its ability to improve insulin sensitivity and reduce inflammation in the body. By lowering the risk of cardiovascular disease, metformin can significantly improve the long-term health outcomes of individuals with diabetes.

4. Improved fertility in women with polycystic ovary syndrome (PCOS)

Metformin is often prescribed to women with polycystic ovary syndrome (PCOS) to improve fertility. It can help regulate menstrual cycles and stimulate ovulation, increasing the chances of conception. Additionally, metformin can also help lower the risk of complications during pregnancy in women with PCOS. This makes it a valuable option for those seeking to enhance their fertility and start a family.

5. Potential anti-cancer properties

Emerging research suggests that metformin may have potential anti-cancer properties. Some studies have shown that metformin may inhibit the growth of cancer cells and reduce the risk of certain types of cancer, such as breast and colon cancer. While more research is needed, this potential benefit of metformin highlights its versatility and importance beyond its role in managing diabetes.

In summary, metformin offers many benefits beyond its primary role in managing diabetes. From its weight management effects to its potential cardiovascular and fertility benefits, metformin is a versatile medication that can improve overall health outcomes in a variety of individuals with different health concerns.

Reasons for Recall

Potential Contamination

In accordance with the FDA's guidelines and regulations, the recall of Metformin Extended Release 500 mg is being initiated due to potential contamination concerns. Substandard levels of a probable carcinogen, N-Nitrosodiethylamine (NDEA), have been detected in certain lots of this medication. NDEA is classified as a probable human carcinogen and long-term exposure to high levels of NDEA may increase the risk of cancer.

Patient Safety

The safety and well-being of our patients is our top priority. The recall of Metformin Extended Release 500 mg is being conducted to ensure that no harmful effects occur as a result of using this medication. This action is taken as a precautionary measure to minimize any potential risks associated with the presence of NDEA above acceptable levels in the affected lots.

Regulatory Compliance

We are committed to strict adherence to all regulatory standards and guidelines. Our company takes this recall seriously as part of our ongoing commitment to quality, safety, and compliance. By initiating this recall, we are demonstrating our commitment to maintaining the highest level of regulatory compliance and ensuring the integrity of our products.

Transparent Communication

We believe in open and transparent communication with our patients and healthcare providers. The recall of Metformin Extended Release 500 mg is being announced to ensure that all individuals who may have been affected are informed promptly. By providing accurate and timely information, we aim to keep our patients and healthcare providers informed and empowered to make the best decisions for their health.

Corrective Action

While the recall may cause inconvenience, we are working diligently to resolve this issue promptly. Our team is actively investigating the root cause of the contamination and implementing corrective actions to prevent reoccurrence. We are committed to addressing this issue swiftly and effectively to ensure the safety and well-being of our patients.

Customer Support

We understand the impact this recall may have on our patients and healthcare providers. Our dedicated customer support team is available to address any questions or concerns related to this recall. We are committed to providing the necessary support and guidance to ensure a smooth recall process and ensure the continued trust and confidence in our products and services.

Impact of Recall

The recall of Metformin Extended Release 500 mg tablets is expected to have a significant impact on patients who rely on this medication to manage their diabetes. Metformin is a commonly prescribed medication for type 2 diabetes, and the extended release formulation allows for once-daily dosing, increasing convenience for patients.

Disruption of Treatment: This recall may disrupt the treatment plan for patients who were taking Metformin Extended Release 500 mg tablets. Those affected will need to consult their healthcare provider to find an alternative treatment option. It is important to continue adhering to the prescribed treatment plan and not discontinue the medication without medical guidance.

Increased Healthcare Costs: Patients who switch to an alternative medication may experience an increase in healthcare costs. The cost of alternative medications may not be covered by insurance or may require higher co-pays. This can place an additional financial burden on patients, especially those with limited financial resources.

Potential Health Risks: The recall of Metformin Extended Release 500 mg tablets is due to the presence of elevated levels of N-nitrosodimethylamine (NDMA), a potential human carcinogen. Continued use of the affected tablets may pose a potential risk to patient health. It is essential for patients to follow the recall instructions provided by the manufacturer and consult their healthcare provider for guidance on alternative treatment options.

Impact on Diabetes Management: For patients who have been successfully managing their diabetes with Metformin Extended Release 500 mg tablets, the recall may disrupt their diabetes management routine. It may take time to find an alternative medication that works as effectively and has a similar dosage schedule. This can lead to fluctuations in blood sugar levels and potential complications associated with uncontrolled diabetes.

Regaining Patient Confidence: The recall highlights the importance of rigorous quality control and monitoring processes in the pharmaceutical industry. It is crucial for manufacturers to address the issue promptly, implement corrective measures, and regain the confidence of patients and healthcare providers. This incident serves as a reminder for patients to stay informed about any medication recalls and to always consult their healthcare provider if they have any concerns.

Alternative Options

1. Glipizide

If you are looking for an alternative to Metformin Extended Release 500 mg, one option to consider is Glipizide. Glipizide is an oral medication that can help lower blood sugar levels in people with type 2 diabetes. It works by stimulating the pancreas to release more insulin, which helps the body process glucose more effectively. Discuss with your doctor if Glipizide is a suitable alternative for you.

2. Pioglitazone

Another alternative to Metformin Extended Release 500 mg is Pioglitazone. Pioglitazone belongs to a class of drugs called thiazolidinediones, which help improve insulin sensitivity and lower blood sugar levels. It also helps reduce the risk of long-term complications associated with diabetes. Talk to your healthcare provider to determine if Pioglitazone is a good option for managing your diabetes.

3. Acarbose

Acarbose is another alternative to consider if you are unable to take Metformin Extended Release 500 mg. Acarbose works by slowing down the digestion of carbohydrates, which helps prevent blood sugar spikes after meals. It can be taken alone or in combination with other diabetes medications. Consult with your doctor to see if Acarbose is a suitable alternative for you.

4. DPP-4 inhibitors

DPP-4 inhibitors, such as Sitagliptin and Saxagliptin, are oral medications that help lower blood sugar levels by increasing the body's production of insulin and reducing the amount of glucose produced by the liver. These medications are often used as an alternative to Metformin and can be taken alone or in combination with other diabetes drugs. Discuss with your healthcare provider if DPP-4 inhibitors are a suitable option for you.

5. Insulin therapy

If other oral medications are not effective in controlling your blood sugar levels, your doctor may recommend insulin therapy as an alternative. Insulin is a hormone that helps regulate blood sugar levels. There are different types of insulin available, including rapid-acting, short-acting, intermediate-acting, and long-acting. Your healthcare provider will determine the appropriate insulin regimen for you based on your individual needs.

Remember, it is important to consult with your healthcare provider before making any changes to your diabetes medication regimen. They can help determine the best alternative option for you based on your specific health condition and medical history.

Metformin extended release 500 mg recall