Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

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 and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

• Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
• Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

• Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: tevarecalls@inmar.com.
• Inmar will provide the materials needed to return their medication and instructions for reimbursement.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The Three Branches of Government Summarized  

Most modern systems of government present in our world today consist of three primary parts: the executive, legislative, and judicial branches of government. These branches differ from country to country in terms of composition, size, function, and importance, but are usually designed to operate best independently of each other on specific aspects of governance. In some countries, the way these ideally independent branches of government work together to govern the country is known as checks and balances.
Legislative
The legislative branch of government is usually composed of a legislature or assembly of individuals representing the people of a given nation. In most cases these representatives are elected by the people in a particular geographic location, such as a county, state, or province, though in some less democratic systems this may not always be true. In the United States, the legislative branch is known as Congress, which is divided into two sections: the House of Representatives and the Senate. This system is known as a bicameral legislature, in which there is a lower and upper house. In countries like the United Kingdom, Canada, as well as many other European nations, the legislative branch consists of a single house called a parliament. The role of the legislative branch of government is to discuss and pass laws for the country, as well as hold the executive branch accountable for its action in implementing and enforcing these laws.
Executive
The executive branch of government generally consists of a president, prime minister, or in some cases, a monarch such as a king, queen, prince, sultan, or emperor. The role of the executive branch is to conduct the day to day affairs of the nation, including domestic and foreign affairs. This usually includes the overall supreme command of the military armed forces, police, and civil administration. Thus, it is usually the responsibility of the executive branch to efficiently implement and enforce the laws passed by the legislative branch. The executive branch is ultimately accountable to the legislative and judicial branches for its actions and policies. In some cases, the monarch is merely a ceremonial position with no actual political power, in which case the executive functions of government are exercised by a prime minister, who is also the leader of the dominant faction within the legislative branch.
Judicial
The judicial branch of government consists of a nation’s courts and judges, which are meant to interpret the laws enacted by the legislative branch as they apply to various situations, and in some countries such as the United States, to determine whether or not laws are valid according to the Constitution. The judicial branch also determines the legality of actions conducted by the executive branch based on current laws. In the United States, the Supreme Court has also developed a special role in developing laws in addition to merely interpreting them. The concept of judicial activism involves the courts making legal decisions about various issues and policies that, in effect, serve as laws, because they establish a legal precedent regarding what can and cannot be done by the other branches of government as well as by citizens.

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