Metformin hydrochloride 500 mg tablets recall

Attention, Metformin users! We want to inform you about an important recall of Metformin hydrochloride 500 mg tablets. Your safety and well-being are our top priority, and we are taking immediate action to address this issue.

What is happening?

Recent testing has revealed that certain batches of Metformin hydrochloride 500 mg tablets may contain higher than acceptable levels of a potential cancer-causing impurity called N-Nitrosodimethylamine (NDMA). Therefore, to ensure your safety, we are recalling these specific batches from the market.

Why is this recall necessary?

The presence of elevated levels of NDMA in pharmaceutical products is a matter of serious concern. Although the risks associated with the levels detected in Metformin hydrochloride 500 mg tablets are currently unknown, we believe it is crucial to be proactive in protecting your health.

What should you do?

If you are currently taking Metformin hydrochloride 500 mg tablets, we urge you to contact your healthcare provider as soon as possible. They will be able to advise you on the next steps to ensure your continued treatment and any necessary adjustments to your medication regimen.

Rest assured, patient safety is our priority.

"As a responsible pharmaceutical company, we take all product recalls seriously. We understand the impact this may have on patients and their families. We apologize for any inconvenience caused and assure you that we are working diligently to resolve this issue."

Overview of Metformin hydrochloride 500 mg tablets

Metformin hydrochloride 500 mg tablets are an effective medication used in the management of type 2 diabetes. It belongs to a class of drugs called biguanides, which work to control blood sugar levels by decreasing the amount of glucose produced by the liver and increasing the sensitivity of muscle and fat cells to insulin. This helps to improve the body's response to insulin and lower blood sugar levels.

Key Features:

Effective Diabetes Management: Metformin hydrochloride 500 mg tablets are widely prescribed for the treatment of type 2 diabetes due to their proven efficacy in controlling blood sugar levels.
Safe and Well-Tolerated: This medication is generally well-tolerated, with common side effects including mild gastrointestinal disturbances such as nausea, diarrhea, or stomach upset.
Weight Management Benefits: Metformin hydrochloride 500 mg tablets have been shown to promote modest weight loss in individuals with type 2 diabetes, making it a favorable option for those looking to manage their weight.
Cardiovascular Benefits: Studies have suggested that metformin may have cardioprotective effects, potentially reducing the risk of cardiovascular events such as heart attack and stroke in individuals with type 2 diabetes.

Uses:

Metformin hydrochloride 500 mg tablets are primarily used to lower blood sugar levels in individuals with type 2 diabetes. It is usually prescribed alongside a healthy diet and regular exercise. This medication can also be used off-label for the treatment of polycystic ovary syndrome (PCOS) and gestational diabetes.

Directions for Use:

Dosage: The usual starting dose for metformin hydrochloride 500 mg tablets is 500 mg once or twice daily. The dose may be gradually increased as needed, under the guidance of a healthcare professional.
Administration: The tablets should be taken with meals to reduce the likelihood of gastrointestinal side effects. Swallow the tablets whole without crushing or chewing.
Monitoring: Regular blood sugar monitoring is recommended to assess the effectiveness of the medication and make any necessary dosage adjustments.
Duration of Use: Metformin hydrochloride 500 mg tablets are typically taken long-term to maintain optimal blood sugar control. It is important to continue taking the medication as directed by a healthcare professional.

It is essential to consult with a healthcare professional before starting or making any changes to your medication regimen. They will evaluate your individual needs and provide personalized guidance for the use of metformin hydrochloride 500 mg tablets.

Section 1: Recall Details

Recall Initiator:

The recall of Metformin hydrochloride 500 mg tablets is being initiated by the manufacturer due to potential contamination issues.

Product Description:

The recalled product is Metformin hydrochloride 500 mg tablets. These tablets are used in the treatment of type 2 diabetes.

Lot Numbers:

Lot Number 12345678
Lot Number 23456789
Lot Number 34567890

Reason for Recall:

The recall is being conducted due to the presence of a potentially harmful impurity, N-Nitrosodimethylamine (NDMA), above acceptable levels in the affected lots of Metformin hydrochloride 500 mg tablets.

Health Risks:

Exposure to NDMA above acceptable levels over a long period of time may increase the risk of cancer.

Next Steps:

Patients who have been prescribed Metformin hydrochloride 500 mg tablets should contact their healthcare provider for guidance.
Pharmacies and retailers should immediately stop dispensing and selling the affected lots of Metformin hydrochloride 500 mg tablets.

Contact Information:

If you have any questions or concerns about this recall, please contact the manufacturer at 1-800-123-4567.

Complete recall information can be found on the manufacturer's website.

Reasons for the recall

Potential presence of N-nitrosodimethylamine (NDMA)

One of the main reasons for the recall of Metformin hydrochloride 500 mg tablets is the potential presence of N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, meaning that long-term exposure to high levels of NDMA may increase the risk of developing cancer.

The presence of NDMA in the affected tablets was discovered during routine testing, and as a precautionary measure, the manufacturer has decided to recall the product to ensure the safety and well-being of consumers.

Quality control issues

Another reason for the recall is the identification of quality control issues during the manufacturing process of Metformin hydrochloride tablets. These issues may affect the potency and purity of the product, leading to potential health risks for patients who rely on its therapeutic effects.

The manufacturer has initiated the recall to address these quality control issues and ensure that only safe and effective products are available to the market.

Compliance with regulatory standards

The recall also stems from the need to comply with regulatory standards set by government health authorities. These authorities have established guidelines and maximum allowable limits for impurities such as NDMA in pharmaceutical products, and the presence of NDMA in the affected Metformin hydrochloride tablets exceeds these limits.

The manufacturer is taking immediate action to rectify the situation and bring their product back into compliance with the necessary regulatory standards.

Section 2: Potential Risks

Risk of prolonged or excessive low blood sugar

One potential risk of taking Metformin hydrochloride 500 mg tablets is the development of prolonged or excessive low blood sugar levels, also known as hypoglycemia. While this is a rare side effect, it is important to be aware of the signs and symptoms, which can include dizziness, confusion, shakiness, and sweating. It is crucial to monitor blood sugar levels regularly and consult a healthcare professional if any concerning symptoms occur.

Possibility of lactic acidosis

Another potential risk associated with the use of Metformin hydrochloride 500 mg tablets is the development of lactic acidosis. Lactic acidosis is a rare but serious condition that occurs when there is a buildup of lactic acid in the body. Symptoms may include muscle pain or weakness, severe fatigue, rapid breathing, stomach pain, and an irregular heartbeat. If any of these symptoms arise, it is important to seek immediate medical attention.

Potential for gastrointestinal side effects

Some individuals taking Metformin hydrochloride 500 mg tablets may experience gastrointestinal side effects. These can include nausea, vomiting, diarrhea, and abdominal discomfort. These side effects are typically mild and resolve on their own, but it is important to discuss any persistent or severe symptoms with a healthcare professional.

Possible drug interactions

Metformin hydrochloride 500 mg tablets may interact with certain medications, increasing the risk of adverse effects. It is crucial to inform healthcare professionals about all medications, including over-the-counter drugs and herbal supplements, being taken. Drug interactions can lead to an increase in side effects or a decrease in the effectiveness of either medication.

Potential for allergic reactions

In rare cases, some individuals may experience an allergic reaction to Metformin hydrochloride 500 mg tablets. Signs of an allergic reaction may include hives, rash, itching, swelling of the face or throat, difficulty breathing, or a rapid heartbeat. If any of these symptoms occur, immediate medical attention should be sought.

Other potential risks to consider

While not as common, there are additional potential risks associated with the use of Metformin hydrochloride 500 mg tablets that should be considered. These can include vitamin B12 deficiency, liver problems, and kidney conditions. Regular monitoring and communication with healthcare professionals are essential to minimize these risks and ensure the safe use of the medication.

Possible side effects

1. Gastrointestinal disorders

Nausea and vomiting: Some individuals may experience nausea or vomiting as a result of taking Metformin hydrochloride 500 mg tablets. This side effect is usually mild and can be managed by taking the medication with food.

Diarrhea: Diarrhea is another common gastrointestinal side effect of Metformin hydrochloride 500 mg tablets. It is important to stay hydrated and consult a healthcare professional if diarrhea persists or becomes severe.

2. Hypoglycemia

Low blood sugar levels: Metformin hydrochloride 500 mg tablets can cause hypoglycemia, which is characterized by symptoms such as dizziness, confusion, and shakiness. It is important to monitor blood sugar levels regularly and seek medical attention if experiencing symptoms of low blood sugar.

3. Lactic acidosis

Buildup of lactic acid: In rare cases, Metformin hydrochloride 500 mg tablets may cause lactic acidosis, a serious condition that can be life-threatening. Symptoms of lactic acidosis include rapid breathing, muscle pain, and weakness. Seek immediate medical attention if experiencing these symptoms.

4. Allergic reactions

Rash and itching: Some individuals may develop an allergic reaction to Metformin hydrochloride 500 mg tablets, resulting in a rash and itching. If experiencing these symptoms, discontinue use and consult a healthcare professional.

Swelling and difficulty breathing: Severe allergic reactions to Metformin hydrochloride 500 mg tablets can cause swelling of the face, lips, tongue, or throat, as well as breathing difficulties. Seek emergency medical attention if experiencing these symptoms.

It is important to note that this is not a complete list of side effects. For a full list, refer to the product information leaflet or consult a healthcare professional.

Section 3: Actions for Consumers

1. Check your medication

If you are taking Metformin hydrochloride 500 mg tablets, check the batch number and expiry date on the packaging. The affected batches are listed in the recall notice. If your medication is from one of these batches, stop taking it immediately.

2. Contact your healthcare provider

If you have been taking Metformin hydrochloride 500 mg tablets from the affected batches, contact your healthcare provider as soon as possible. They will be able to guide you on the next steps to take and may prescribe an alternative medication if necessary.

3. Monitor your health

While the risk of contamination is low, it is important to monitor your health for any unexpected symptoms or adverse reactions. If you experience any unusual side effects or are concerned about your health, contact your healthcare provider for further guidance.

4. Dispose of the medication properly

If your Metformin hydrochloride 500 mg tablets are from the affected batches, do not dispose of them in the regular trash. Follow the instructions provided in the recall notice for proper disposal methods to ensure the medication is safely removed from circulation.

5. Stay informed

Keep yourself updated on the latest developments regarding the recall of Metformin hydrochloride 500 mg tablets. Follow the instructions provided by the manufacturer and regulatory agencies to ensure the safety of your medication and health.

What consumers should do

If you have purchased or currently use Metformin hydrochloride 500 mg tablets, here are some important steps you should take:

Check the lot number on the packaging of the medication. The affected lot numbers can be found on the FDA's website.
If your medication is part of the recalled lot, immediately contact your healthcare provider or pharmacist. They will be able to provide guidance on what to do next.
Do not stop taking your medication without consulting your healthcare provider. They will be able to assess your specific situation and determine if alternative treatments or medications are necessary.
Monitor your health closely for any unusual symptoms or side effects. If you experience any new or worsening symptoms, contact your healthcare provider immediately.
Stay informed about the latest updates on the recall. Regularly check the FDA's website or sign up for email notifications to ensure you have the most up-to-date information.
If you have any unused medication from the recalled lot, do not dispose of it in the regular trash. Follow the proper disposal instructions provided by your healthcare provider or local authorities.

By taking these actions, you can ensure your safety and stay informed about the recall of Metformin hydrochloride 500 mg tablets.

Section 4: Actions for Healthcare Providers

1. Identify the affected products

Review your inventory of Metformin hydrochloride 500 mg tablets to identify the affected products. This recall applies to specific batches of Metformin hydrochloride 500 mg tablets, manufactured by XYZ Pharmaceuticals. Refer to the list of affected batch numbers provided by the company.

2. Inform patients and discontinue use

Contact patients who have been prescribed Metformin hydrochloride 500 mg tablets and inform them about the recall. Advise them to discontinue use of the specific batches of the product listed in the recall notice. Provide alternative treatment options and schedule a visit to assess any potential adverse effects.

3. Return or replace affected products

Arrange for the return or replacement of the affected products. Contact the distributor or manufacturer to initiate the return process. Ensure that proper documentation is maintained for the returned products.

4. Report any adverse events

Report any adverse events or product quality issues related to the recalled Metformin hydrochloride 500 mg tablets. Follow the established reporting procedures of your country's regulatory authorities and provide all necessary details regarding the affected products and any associated patient reactions.

5. Educate patients on signs and symptoms of complications

Educate patients on the signs and symptoms of complications related to the use of Metformin hydrochloride tablets. Advise them to monitor their blood glucose levels and be vigilant for any symptoms such as dizziness, weakness, confusion, or unusual fatigue. Encourage them to seek immediate medical attention if they experience any such symptoms.

By following these actions, healthcare providers can ensure the safety and wellbeing of their patients who may be using Metformin hydrochloride 500 mg tablets. The recall is a precautionary measure to address any potential risks associated with the affected batches and to prevent any further harm to patients.