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Sam Coffey Published in the Sun Sentinel, “Patience key as we await COVID-19 vaccine”

As the COVID-19 health care crisis continues to ravage our communities, many are anxiously awaiting the day when a vaccine is developed to eradicate this illness. And while these are valid and important hopes, it’s important that we take a patient approach and not let our emotions overtake rational thought and important scientific research. Over … Continue reading “Sam Coffey Published in the Sun Sentinel, “Patience key as we await COVID-19 vaccine””

Sean Goldstein Recognized by the American Institute of Trial Lawyers Top 40 Under 40 2020

Personal Injury Lawyer Sean Goldstein of Coffey Trial Law has been recognized by the American Institute of Trial Lawyers in their Top 40 Under 40 list for 2020. Top 40 Under 40 is a professional organization composed of the top trial lawyers from each state or region who are under the age of 40. Membership … Continue reading “Sean Goldstein Recognized by the American Institute of Trial Lawyers Top 40 Under 40 2020”

Sean Goldstein Listed in Best Lawyers “Ones to Watch” in 2020

Accident Attorney Sean Goldstein of Coffey Trial Law has been listed in Best Lawyers “Ones to Watch” list. The “Ones to Watch” designation are recognitions given to attorneys who are earlier in their careers for outstanding professional excellence in private practice in the United States. Our “Ones to Watch” recipients typically have been in practice … Continue reading “Sean Goldstein Listed in Best Lawyers “Ones to Watch” in 2020″

Diabetes Drug Recalled Due to High Levels of Substance that ‘Could Cause Cancer,’ FDA Says

Marksans Pharma Limited had expanded its voluntary recall of Metformin Hydrochloride Extended-Release Tablets A drug commonly used to treat Type 2 diabetes has been recalled due to cancer concerns. This week, the Food and Drug Administration announced that Marksans Pharma Limited had expanded its voluntary recall of Metformin Hydrochloride Extended-Release Tablets. An additional 76 unexpired lots were … Continue reading “Diabetes Drug Recalled Due to High Levels of Substance that ‘Could Cause Cancer,’ FDA Says”

Sanofi, GSK face U.S. investigation over potential Zantac carcinogen link

The U.S. Department of Justice has opened an investigation into whether drugmakers including Sanofi SA failed to disclose to the federal government information about the potential presence of a probable carcinogen in the heartburn drug Zantac. Sanofi and GlaxoSmithKline in separate filings with the U.S. Securities and Exchange Commission on Wednesday said they received civil … Continue reading “Sanofi, GSK face U.S. investigation over potential Zantac carcinogen link”

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out … Continue reading “Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity”

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. Granules’ test results showed NDMA levels above the FDA acceptable limit … Continue reading “Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity”

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 … Continue reading “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)”

FDA Updates and Press Announcements on NDMA in Metformin

The FDA is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below. The companies are recalling metformin due to the possibility the medicines could contain nitrosodimethylamine (NDMA) above the acceptable intake limit. Granules Pharmaceuticals – 12 lots Lupin Pharmaceuticals – All lots (expansion of previous recall) Avkare … Continue reading “FDA Updates and Press Announcements on NDMA in Metformin”