Valisure’s FDA Citizen Petitions

With roughly 80% of all ingredients in U.S. medications coming from India and China, Valisure’s mission is to bring transparency and increased quality to the pharmaceutical industry and deliver these benefits to consumers. Given the substantial and alarming concerns within the supply chain, Valisure has rocked the foundation of the pharmacy and consumer products industry by filing FDA Citizen Petitions over the years.

On June 13, 2019, Valisure announced the detections of N, N-Dimethylformamide (“DMF”) in specific lots of the drug valsartan, an angiotensin II receptor blocker (“ARB”). DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (“WHO”) and the International Association for Research of Cancer (“IARC”).

On March 2, 2020, Valisure announced its detections of  N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Valisure submitted a petition to urge FDA to request recalls for the identified lots of metformin consistent with the FDA’s mandate to ensure the safety of the drug supply in America. resulting in recalls from five companies.

On September 13, 2019, Valisure announces its discovery of the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication. DATA? This resulted in the FDA requesting manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.

Since these findings in prescription drug products, Valisure has also made a global impact in the consumer healthcare products industry. When confirmed cases of COVID-19 began to rise causing multiple shortages of products, the FDA announced a temporary policy to prepare hand sanitizer. Thus companies began mass-producing hand sanitizer in quantity over quality.

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene. In March of 2021, Valisure announced its detections of benzene, a known human carcinogen, in multiple brands of hand sanitizer, Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention, the International Agency for Research on Cancer, the World Health Organization, and other regulatory agencies. Of the 260 hand sanitizer products, 17% of batches contained benzene. Valisure submitted a petition to FDA to take action on the contamination and update its guidance on benzene, resulting in the recalls of  ArtNaturals products and Scentsational Soaps & Candles products.

In May of 2021, Valisure announced the detection of benzene in several brands of sunscreen. Of the 294 hand sanitizer products tested, 27% of batches contained benzene. Valisure submitted a petition to FDA, resulting in the recalls of Johnson & Johnson's Neutrogena & Aveeno products, and Coppertone's products.

Valisure’s most recent announcement in November of 2021, was the detection of benzene in several brands of antiperspirant body sprays.  Of the 108 body spray products tested, 54% of batches contained benzene. Valisure submitted another petition to FDA, resulting in the recalls of Procter & Gamble’s Old Spice, Secret, Aussie, Herbal Essences, & Waterl<ss products.

Valisure’s FDA Citizen Petitions

April 13, 2022

With roughly 80% of all ingredients in U.S. medications coming from India and China, Valisure’s mission is to bring transparency and increased quality to the pharmaceutical industry and deliver these benefits to consumers. Given the substantial and alarming concerns within the supply chain, Valisure has rocked the foundation of the pharmacy and consumer products industry by filing FDA Citizen Petitions over the years.

On June 13, 2019, Valisure announced the detections of N, N-Dimethylformamide (“DMF”) in specific lots of the drug valsartan, an angiotensin II receptor blocker (“ARB”). DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (“WHO”) and the International Association for Research of Cancer (“IARC”).

On March 2, 2020, Valisure announced its detections of  N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Valisure submitted a petition to urge FDA to request recalls for the identified lots of metformin consistent with the FDA’s mandate to ensure the safety of the drug supply in America. resulting in recalls from five companies.

On September 13, 2019, Valisure announces its discovery of the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication. DATA? This resulted in the FDA requesting manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.

Since these findings in prescription drug products, Valisure has also made a global impact in the consumer healthcare products industry. When confirmed cases of COVID-19 began to rise causing multiple shortages of products, the FDA announced a temporary policy to prepare hand sanitizer. Thus companies began mass-producing hand sanitizer in quantity over quality.

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene. In March of 2021, Valisure announced its detections of benzene, a known human carcinogen, in multiple brands of hand sanitizer, Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention, the International Agency for Research on Cancer, the World Health Organization, and other regulatory agencies. Of the 260 hand sanitizer products, 17% of batches contained benzene. Valisure submitted a petition to FDA to take action on the contamination and update its guidance on benzene, resulting in the recalls of  ArtNaturals products and Scentsational Soaps & Candles products.

In May of 2021, Valisure announced the detection of benzene in several brands of sunscreen. Of the 294 hand sanitizer products tested, 27% of batches contained benzene. Valisure submitted a petition to FDA, resulting in the recalls of Johnson & Johnson's Neutrogena & Aveeno products, and Coppertone's products.

Valisure’s most recent announcement in November of 2021, was the detection of benzene in several brands of antiperspirant body sprays.  Of the 108 body spray products tested, 54% of batches contained benzene. Valisure submitted another petition to FDA, resulting in the recalls of Procter & Gamble’s Old Spice, Secret, Aussie, Herbal Essences, & Waterl<ss products.

Valisure’s FDA Citizen Petitions

With roughly 80% of all ingredients in U.S. medications coming from India and China, Valisure’s mission is to bring transparency and increased quality to the pharmaceutical industry and deliver these benefits to consumers. Given the substantial and alarming concerns within the supply chain, Valisure has rocked the foundation of the pharmacy and consumer products industry by filing FDA Citizen Petitions over the years.

On June 13, 2019, Valisure announced the detections of N, N-Dimethylformamide (“DMF”) in specific lots of the drug valsartan, an angiotensin II receptor blocker (“ARB”). DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (“WHO”) and the International Association for Research of Cancer (“IARC”).

On March 2, 2020, Valisure announced its detections of  N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Valisure submitted a petition to urge FDA to request recalls for the identified lots of metformin consistent with the FDA’s mandate to ensure the safety of the drug supply in America. resulting in recalls from five companies.

On September 13, 2019, Valisure announces its discovery of the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication. DATA? This resulted in the FDA requesting manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.

Since these findings in prescription drug products, Valisure has also made a global impact in the consumer healthcare products industry. When confirmed cases of COVID-19 began to rise causing multiple shortages of products, the FDA announced a temporary policy to prepare hand sanitizer. Thus companies began mass-producing hand sanitizer in quantity over quality.

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene. In March of 2021, Valisure announced its detections of benzene, a known human carcinogen, in multiple brands of hand sanitizer, Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention, the International Agency for Research on Cancer, the World Health Organization, and other regulatory agencies. Of the 260 hand sanitizer products, 17% of batches contained benzene. Valisure submitted a petition to FDA to take action on the contamination and update its guidance on benzene, resulting in the recalls of  ArtNaturals products and Scentsational Soaps & Candles products.

In May of 2021, Valisure announced the detection of benzene in several brands of sunscreen. Of the 294 hand sanitizer products tested, 27% of batches contained benzene. Valisure submitted a petition to FDA, resulting in the recalls of Johnson & Johnson's Neutrogena & Aveeno products, and Coppertone's products.

Valisure’s most recent announcement in November of 2021, was the detection of benzene in several brands of antiperspirant body sprays.  Of the 108 body spray products tested, 54% of batches contained benzene. Valisure submitted another petition to FDA, resulting in the recalls of Procter & Gamble’s Old Spice, Secret, Aussie, Herbal Essences, & Waterl<ss products.

With roughly 80% of all ingredients in U.S. medications coming from India and China, Valisure’s mission is to bring transparency and increased quality to the pharmaceutical industry and deliver these benefits to consumers. Given the substantial and alarming concerns within the supply chain, Valisure has rocked the foundation of the pharmacy and consumer products industry by filing FDA Citizen Petitions over the years.

On June 13, 2019, Valisure announced the detections of N, N-Dimethylformamide (“DMF”) in specific lots of the drug valsartan, an angiotensin II receptor blocker (“ARB”). DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (“WHO”) and the International Association for Research of Cancer (“IARC”).

On March 2, 2020, Valisure announced its detections of  N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Valisure submitted a petition to urge FDA to request recalls for the identified lots of metformin consistent with the FDA’s mandate to ensure the safety of the drug supply in America. resulting in recalls from five companies.

On September 13, 2019, Valisure announces its discovery of the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication. DATA? This resulted in the FDA requesting manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.

Since these findings in prescription drug products, Valisure has also made a global impact in the consumer healthcare products industry. When confirmed cases of COVID-19 began to rise causing multiple shortages of products, the FDA announced a temporary policy to prepare hand sanitizer. Thus companies began mass-producing hand sanitizer in quantity over quality.

In late 2020, Valisure expanded its testing capabilities to include analysis for benzene. In March of 2021, Valisure announced its detections of benzene, a known human carcinogen, in multiple brands of hand sanitizer, Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention, the International Agency for Research on Cancer, the World Health Organization, and other regulatory agencies. Of the 260 hand sanitizer products, 17% of batches contained benzene. Valisure submitted a petition to FDA to take action on the contamination and update its guidance on benzene, resulting in the recalls of  ArtNaturals products and Scentsational Soaps & Candles products.

In May of 2021, Valisure announced the detection of benzene in several brands of sunscreen. Of the 294 hand sanitizer products tested, 27% of batches contained benzene. Valisure submitted a petition to FDA, resulting in the recalls of Johnson & Johnson's Neutrogena & Aveeno products, and Coppertone's products.

Valisure’s most recent announcement in November of 2021, was the detection of benzene in several brands of antiperspirant body sprays.  Of the 108 body spray products tested, 54% of batches contained benzene. Valisure submitted another petition to FDA, resulting in the recalls of Procter & Gamble’s Old Spice, Secret, Aussie, Herbal Essences, & Waterl<ss products.

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