Categories
Uncategorized

Viona Pharmaceuticals Inc., to Voluntarily Recall Metformin HCI Extended- Release Tablets (USP 750 mg) due to a N-Nitrosodimethylamine (NDMA) Impurity

As of 01/07/2022, Viona Pharmaceuticals Inc., located in Cranford, New Jersey, began to voluntarily recall 23 lots of Metformin HCI Extended- Release Tablets (USP 750 mg) due to an NDMA impurity. This was determined after an Out of Specification (OOS) test on batch M008132 found traces of NDMA. 

NDMA is classified as a “probable human carcinogen”, or a substance that could cause cancer. NDMA is a known environmental contaminant and can be found in water and foods like meat, dairy products, and vegetables. 

Metformin is used as an adjunct to diet and exercise to improve blood glucose in adults with type 2 diabetes. The products themselves can be identified as white/off-white, capsule shaped, uncoated tablets with the letter “Z”, “C” on one side and “20” on the other. 

Those who are using Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are to continue taking their medication and contact their physician regarding an alternative treatment. It could be dangerous for patients to stop taking their Metformin without first talking to their healthcare professionals, according to the FDA.

Fortunately, neither Viona Pharmaceuticals Inc nor Cadila Healthcare Limited (manufacturer) have received reports of adverse events related to the recall or the medicine. 

Below, we have listed the recalled lots of Metformin HCI Extended-Release Tablets, USP 750 mg which were distributed nationwide to various distributors. 

Sr. Number  Batch Number Expiration Date 
1. M008130 06/2022
2. M008131 06/2022
3. M008132 06/2022
4. M008133 06/2022
5. M010080 07/2022
6. M010081 07/2022
7. M011029 08/2022
8. M011030 08/2022
9. M011031 08/2022
10. M011032 08/2022
11. M011304 08/2022
12. M013394 09/2022
13. M013395 09/2022
14. M013396 09/2022
15. M013966 09/2022
16. M013967 09/2022
17. M100831 12/2022
18. M100832 12/2022
19. M100833 01/2023
20. M100834 01/2023
21. M101267 01/2023
22. M102718 01/2023
23. M102719 01/2023

 

Viona Pharmaceuticals Inc., are letting consumers know about the recall via email and mail as well as arranging for the return of the recalled products to the following address: 

Inmar Pharmaceuticals Services-Recalls

3845 Grand Lakes Way,

Grand Prairie, Texas 75050.

For more information, please visit the following link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0

If you or someone you know has been affected by the harmful impurities that could be found in Metformin, please do not hesitate to contact Boesen Law, LLC at (303) 999-9999 or visit our website at https://www.boesenlaw.com for more information.

Categories
Team Members Uncategorized

Talk With a Team Member: Liz

[:en]

How long have you worked at Boesen Law?

I’ve worked with Boesen Law for nearly 7 years now!

Describe a fun memory/experience you have had since working here.

It’s hard to pick just one. I’d have to say that one of my fondest memories was having a Chips n Guac birthday party that also had cake too!

What drew you to wanting to work in the legal field?

My falling into the legal field was by fate. I had relocated from another state (yes, I’m a transplant!) and needed a chance. The rest is history!

What do you like most about working in your position and why?

I enjoy problem solving. A lot of what we do everyday involves fixing an issue or helping someone. It is very heartwarming when you can put a smile on someone’s face who may not otherwise have been able to help themselves.

What do you like to do in your free time?

I spend a lot of time gardening, walking outside with my family, and improving my home.

Favorite Food, Favorite TV show/movie, Favorite Quote

Food: Pho and Sushi, Favorite Show: Archer, Favorite Quote: if at first you don’t succeed, try, try again.

Best piece of (general) advice received?

Never say “Just”. A wise man and wealthy entrepreneur once shared this with me. You never “just” do something. Everything you do is important.[:]

Categories
News Uncategorized

$41 Million Dollar Verdict Issued in Pelvic Mesh Lawsuit

[:en]A jury ruled in favor of a Pennsylvania woman to the tune of $41 million dollars yesterday. The woman claimed that her pelvic mesh developed by medical device company Ethicon caused her severe discomfort and other injuries. Ethicon is a subsidiary company of Johnson & Johnson.

What is a pelvic mesh?

A pelvic mesh is a medical device designed to help with involuntary urination.

Is this lawsuit the first of its kind to be heard?

Unfortunately, no. The legal representation working on Mrs. Emmett’s case has also won six other verdicts in the multi-million dollar range to date.

What is the lawsuit based on?

Suzanne Emmett, the woman who filed the lawsuit, had to undergo numerous surgeries to address injuries and pain relating to the mesh according to an article posted by Philly.com. In addition to the pain and discomfort, Mrs. Emmett’s attorneys also claimed that Johnson & Johnson was aware of the failure rate of their pelvic mesh, but chose not to reveal that information to the Food and Drug Administration (FDA).

What is Johnson & Johnson’s response?

The company released a statement saying that they stand by the quality of their product and are planning to appeal the verdict.

I have been injured by a pelvic mesh product. What are my options?

If you or a loved one have been injured by a pelvic mesh product contact our office at (303)-999-9999 or (303)-835-9342 to schedule a free consultation and speak with one of our experienced attorneys. Please also visit our website here for additional information.[:]

Categories
Social Security Disability Uncategorized

How to Begin the SSDI Application Process

[:en]Are you are interested in applying for Social Security Disability, but not sure how to go about it? Enlisting the help of an attorney can make navigating the process a lot smoother and more successful the first time applying.

If you are interested in applying for benefits and are interested in having representation, here’s what the process can look like.

The First Step

  • Whether submitting a consultation request form online or calling our office – this is the first step towards getting connected with our Social Security Team. Once a request is submitted or made, we reach out to follow up and get the individual connected with our Social Security Disability attorney and/or paralegals. They will assist you with the application process as well as answer any questions you may have.

Set up a Meeting Time

  • Our team will then schedule a time for you to come down to our offices for a meeting. On a case by case basis, our team can go out to meet the individual if they are unable to travel to our offices. At this initial meeting, the disability benefits application process begins – and you are on your way to (hopefully) receiving disability benefits!

If you or a loved one are interested in applying for Social Security Disability benefits please contact our office at (303)-999-9999 or (303)-835-9342. Please also visit our website at www.boesenlaw.com​ for additional information.

[:]