Recall of Metformin Hydrochloride ER Tablets

Amneal Pharmaceuticals LLC Bridgewater is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. They were alerted by the U.S. FDA when testing seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, it showed Nitrosodimethylamine (NDMA) amounts above acceptable consumer FDA levels. Out of caution Amneal agreed to recall all seven lots and has not reported any adverse events directly related to the recall.

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Why is it being recalled?

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.1 With levels above admissible according to the FDA it is being recalled ensuring no adverse reactions arise during consumption. If any adverse reactions are experienced you can submit them online here or find more information on how to mail or fax here.

What products are being recalled?

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.1

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.1

What’s next?

  • Because Metformin is used to treat serious medical conditions, patients taking the recalled Metformin should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.

Sources:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended#recall-announcement
  2. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin

Quick Facts About Diabetes

In recognition of National Diabetes Education Week, we are sharing some important information about this disease state that affects nearly 23.6 million Americans.

What is Diabetes?

  1. Diabetes is associated with high levels of sugar in the blood
  2. There are two classifications of diabetes
    1. Type I – your body doesn’t produce insulin
    2. Type 2 – your body doesn’t use insulin properly or is resistant to the effects of insulin
  3. Type 2 diabetes is much more prevalent and is typically diagnosed as an adult
  4. Diabetes increases your risk of heart disease, kidney failure and blindness

What are some of the risk factors for diabetes?

  1. Obesity
  2. Age > 45
  3. Physical inactivity
  4. High carbohydrate diet

What can people do to prevent diabetes?

  1. Increase physical activity – at least 150 minutes/week of moderate-intense aerobic exercise
  2. Well-balanced diet
  3. Limit alcohol consumption
  4. Maintain a healthy weight

Screening for diabetes should begin for all adults at the age of 45 unless they have pre-existing risk factors such as obesity.  If risk factors exist, screening should begin after the age of 18.

Diabetes is a treatable condition, but early identification and treatment is important to prevent serious complications.  If you have not been tested for diabetes, talk to your physician to see if screening is appropriate for you.

Do You Take an Aspirin a Day?

On May 2nd, The Food and Drug Administration (FDA) released a report regarding the use of daily aspirin to prevent a heart attack and stroke. The FDA’s findings may drastically alter how the health care industry utilizes daily aspirin therapy.

Background:
A number of patients take a daily aspirin due to the belief that it reduces their risk of having a heart attack or stroke.

“Primary Prevention” – Refers to patients with diabetes, family history of heart disease, high blood pressure and high cholesterol who have an increased risk of heart attacks and stroke and use aspirin as prevention (before either of these events occur).

“Secondary Prevention” – Refers to the use of daily aspirin therapy for patients who have had a heart attack, stroke, or having known coronary artery disease. Secondary prevention use of aspirin has well established benefits and significantly reduces the chance of a second heart attack or stroke.

The Update:
The FDA has reviewed new data regarding aspirin use for primary prevention and concluded that there is insufficient evidence at this time to support routine use of daily aspirin therapy in these patients.

What does this mean for you? 
If you have not had a heart attack, stroke, or have known coronary heart disease and you take a daily aspirin, talk to your physician about the need for continued use of aspirin and weigh the risk versus benefit of prolonged aspirin therapy.

Monitoring Your Blood Sugar

Monitoring blood sugar levels is an essential part of diabetes care. This provides the information needed to make adjustments to diet, exercise and medications. Waiting until symptoms of low or high blood sugar levels develop is a recipe for disaster.

Many things can cause blood sugar levels to change, such as: diet, exercise, stress, illness, drugs, and simply the time of day. Foods high in carbohydrates, emotional stress, infections, other medications, and early morning hours can cause blood sugar levels to rise. On the other hand, exercising can cause blood sugar levels to decrease.

Blood sugar levels can be measured easily at home or anywhere. Most blood sugar monitoring devices use a drop of blood obtained by pricking the tip of the finger with a small lancet. Most people find the pricking nearly painless. The machines are smaller than a deck of cards.

It is a good idea to keep a record of your blood sugar levels and report them to your doctor or nurse for dose adjustments of your medicines if necessary. Many people can learn to adjust the insulin dose on their own as necessary.