Metformin Hydrochloride ~ Marksans Pharma Nationwide Recall


Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

“Label, Time-Cap Labs, Inc. Metformin Hydrochloride 500mg tablets”

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Risk Statement: 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. Marksans Pharma Limited has not received any reports of adverse events related to this recall to date.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg

Lot #: XP9004

Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot. Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.

Metformin Hydrochloride – Teva Pharmaceuticals Nationwide Recall


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.
NDC Product Description Lot Number Expiration
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1329548A 06/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1338302M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348968M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348969M 11/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348970M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1376339M 09/2021
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1323460M 06/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1330919M 06/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1338300A 10/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1341135M 12/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1391828M 11/2021
62037-577-01 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count 1333338M 08/2020
62037-577-01 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count 1333339A 08/2020
62037-577-10 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count 1354471A 02/2021

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 500 mg, 100 tablets”

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.

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 750 mg, 100 tablets”

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.

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 500 mg, 1000 tablets”

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

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 750 mg, 1000 tablets”

  • 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.

 

Marxism? Socialism? what ism are you?


beaseedforchangestickersGREENIt’s another rant …

So, is anyone else finding it almost amusing to see how easy folks seem to throw out labels to describe the actions comments and stance of candidates of the democratic party in a time when this government is seemingly in a  kleptocracy moment while living a kakistocracy with a wannabe autocratic tendencies…

trump, is NOT popular and lost that vote by approximately 3Million  and the plan to change America was set a while back and it appears or seems Mcconnell and the other republicans like paul ryan were waiting for their chance …. and if you remember ryan’s comments, he said something about how he has been waiting for a “Unified republican government”.  Thing is, no one really wanted that acting gig until the birther grabbed us by the …bleep and while setting all our government agencies on fire, the rule of law, regular order, and norms being replaced with dic-tator wannabe behavior.  NOW, we need to trust the Democratic Party because our morality seems at risk each day in the hands of republicans! This makes you think back to at least POTUS41 … Not too long you’ll get sick but then reality steps in as POC continue to be targeted, police seem triggered more than ever and the problem of a certain group of males continues to gain access to guns hurting others and in most cases, themselves and that is a shame. We have more schools on lockdown, several babies have died; there are now lockdown drills, some states have given teachers guns yet, another mass shooting occurs but nothing changes. There was a case of a teacher threatening to shoot her students having just had training… It makes you wonder what could go wrong and sadly more unarmed black men and women are dying or are dead!

So, the whole thoughts prayers, etc are NOT enough in this era of trump

The idea that an activist is actually run over and some states decide to pass red flag laws but can’t improve background checks are amazingly offensive.   We should all know that even folks belonging to the NRA think better background checks are reasonable but the gun industry is very strong and so when its fav pr organization says to jump many rs and most do jump … though in this era of trump many many instances of violence have erupted, it also will be a timeline few will want to remember in the new year of 2021

We have to remember the bush timeline, aside from the obvious is sad; the guy acted impetuously then drove our economy into a ditch literally while Wall Street’s “creative accounting procedures” finally came to an ugly head. There was once an epic documentary called  House of cards by David Faber on Cnbc. It was a cruel reminder and or an awakening at how greed affects the mind; it was a truthful documentation of the nasty journey our economy took … for whom, by whom and how it (they) brought all of us down with them knowing the Government would pay for it all along …

Unfortunately, the current trump unreality show doesn’t look at all like the one we watched shortly after our financial system collapsed because this is a moment in time when the question below isn’t so far fetched …  or worse a dystopian society? 

Are You having an existential crisis?

The existential crisis is something many people may face at one point or another in their lives when the world seems to become less meaningful and purposeful. People may question the inner logic of social systems, of their religion, of everything they have once held true, and they do so while becoming much more conscious of the brevity of life.

What is an existential issue?

Quite simply, are issues that have to do with the plight of human existence, with the meaning of life, and what meaning, if any, our lives have.

trump has definitely set off a cause and effect with certain behaviors of human nature

… is anyone else questioning their inner selves? hoping trump supporters are; on what it means to affirm one’s own individual personal  choices and consequences for such choices …and yes in this current hostile environment living an authentic life is important but at risk

If we have to subscribe to labels … idk call me a Marxist who believes in Socialism at this time.  I also believe in capitalism but only with a lower case c …   We need someone who cares, who is socially responsible and who believes the gap between the haves and have none needs to shrink; school me …what can be wrong with caring for all of the people of the US … not just the one percent… especially since that one percent has been wheeling and dealing;  and that attitude about prosperity trickling down to Mainstreet is still bs .  You have to admit it is time for a change.

Obama was not a socialist or a Marxist … he was is a centrist, a person whose political opinions are not extreme: a person whose beliefs fall between those of liberals and conservatives … Question is what do trump supporters call him now?

Nativegrl77