FDA Updates Hydrochlorothiazide Label for Nonmelanoma Skin Cancer FDA Updates Hydrochlorothiazide Label for Nonmelanoma Skin Cancer
Hydrochlorothiazide is associated with an increased risk of nonmelanoma skin cancer, according to updates to the medication's label.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - August 24, 2020 Category: Cancer & Oncology Tags: Cardiology News Source Type: news

AstraZeneca completes divestment agreement with Atnahs Pharma for established hypertension medicines
AstraZeneca today announced that it has completed the previously communicated agreement with Atnahs Pharma (Atnahs) to divest its global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination). (Source: World Pharma News)
Source: World Pharma News - March 2, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

More Side Effects Seen With Guideline-Recommended Chlorthalidone
THURSDAY, Feb. 20, 2020 -- In real-world practice, chlorthalidone use is not associated with significant cardiovascular benefits versus hydrochlorothiazide, but it is associated with a greater risk for renal and electrolyte abnormalities, according... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 20, 2020 Category: Pharmaceuticals Source Type: news

Blood Pressure Med Tied to Harmful Side Effects
Current guidelines recommend the drug chlorthalidone (Thalitone) as the first-line diuretic. But it can have serious side effects that can be avoided with another diuretic, hydrochlorothiazide (Hydrodiuril), researchers say. (Source: WebMD Health)
Source: WebMD Health - February 18, 2020 Category: Consumer Health News Source Type: news

AstraZeneca divests rights to established hypertension medicines
AstraZeneca has agreed to sell the global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination) to Atnahs Pharma (Atnahs). (Source: World Pharma News)
Source: World Pharma News - January 27, 2020 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

hydralazine (Apresoline) vs. hydrochlorothiazide (Microzide)
Title: hydralazine (Apresoline) vs. hydrochlorothiazide (Microzide)Category: MedicationsCreated: 11/8/2019 12:00:00 AMLast Editorial Review: 11/8/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - November 8, 2019 Category: Cardiology Source Type: news

enalapril and hydrochlorothiazide (Vaseretic)
Title: enalapril and hydrochlorothiazide (Vaseretic)Category: MedicationsCreated: 4/3/1999 12:00:00 AMLast Editorial Review: 10/23/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - October 23, 2019 Category: Cardiology Source Type: news

captopril and hydrochlorothiazide (Capozide)
Title: captopril and hydrochlorothiazide (Capozide)Category: MedicationsCreated: 6/6/1999 12:00:00 AMLast Editorial Review: 10/23/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - October 23, 2019 Category: Cardiology Source Type: news

Aldoril (Methyldopa-Hydrochlorothiazide) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 15, 2019 Category: Drugs & Pharmacology Source Type: news

Torrent Pharma recalls 74k bottles of hypertension drug from US
As per the report, Torrent Pharma Inc is recalling 17,088 bottles of Losartan Potassium /Hydrochlorothiazide tablets, USP 50mg/12.5mg from the same markets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 13, 2019 Category: Pharmaceuticals Source Type: news

Medical News Today: More batches of common hypertension drug taken off the market
Torrent Pharmaceuticals Ltd. is withdrawing more batches of Losartan potassium tablets, USP and Losartan potassium/hydrochlorothiazide tablets, USP. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - September 27, 2019 Category: Consumer Health News Tags: Hypertension Source Type: news

FDA Expands Recall Of Blood Pressure Drugs Again
(CNN) — Torrent Pharmaceuticals Ltd. has expanded its voluntary recall of two blood pressure medications after trace amounts of a potentially cancer-causing impurity were found during testing. The recall affects Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets. Tests of some of those medications revealed amounts of N-methylnitrosobutyric acid (NMBA) that were above the US Food and Drug Administration’s daily acceptable levels. This recall is related to the valsartan recall that has been expanded multiple times since July, when separate lots of blood pressure medications from dif...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 24, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Syndicated CBSN Boston CNN Recall Valsartan Source Type: news

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

valsartan/hydrochlorothiazide (Diovan HCT)
Title: valsartan/hydrochlorothiazide (Diovan HCT)Category: MedicationsCreated: 3/2/2005 12:00:00 AMLast Editorial Review: 8/19/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - August 19, 2019 Category: Cardiology Source Type: news

benazepril and hydrochlorothiazide (Lotensin HCT)
Title: benazepril and hydrochlorothiazide (Lotensin HCT)Category: MedicationsCreated: 7/23/1998 12:00:00 AMLast Editorial Review: 8/15/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - August 15, 2019 Category: Cardiology Source Type: news

bisoprolol and hydrochlorothiazide (Ziac)
Title: bisoprolol and hydrochlorothiazide (Ziac)Category: MedicationsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 8/12/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - August 12, 2019 Category: Cardiology Source Type: news

lisinopril and hydrochlorothiazide (Zestoretic, Prinzide)
Title: lisinopril and hydrochlorothiazide (Zestoretic, Prinzide)Category: MedicationsCreated: 7/23/1998 12:00:00 AMLast Editorial Review: 7/24/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - July 24, 2019 Category: Cardiology Source Type: news

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 23, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

triamterene and hydrochlorothiazide
Title: triamterene and hydrochlorothiazideCategory: MedicationsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 7/8/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - July 8, 2019 Category: Cardiology Source Type: news

Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA (N-Nitroso-N ­ Methyl-4-aminobutyric acid) Impurity.
Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 27, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lasix (furosemide) vs. hydrochlorothiazide
Title: Lasix (furosemide) vs. hydrochlorothiazideCategory: MedicationsCreated: 6/7/2019 12:00:00 AMLast Editorial Review: 6/7/2019 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - June 7, 2019 Category: Drugs & Pharmacology Source Type: news

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 5, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up
A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 24, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Ca...
Source: FDA Center for Drug Evaluation and Research - What's New - May 23, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceuti
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 22, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical in (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 21, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Recall of blood pressure drug losartan expanded
If you take blood pressure medicine, you'll want to double-check your bottle. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. (Source: CNN.com - Health)
Source: CNN.com - Health - April 20, 2019 Category: Consumer Health News Source Type: news

Recall Of Blood Pressure Drug Losartan Expanded
(CNN) — If you take blood pressure medicine, you’ll want to double-check your bottle. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. Tests found trace amounts of a potentially cancer-causing impurity called N-methylnitrosobutyric acid in some of these drugs. The company is recalling 36 additional lots, it said Thursday. A full list of recalled drugs is available on the US Food and Drug Administration website. Some of the recalled blood pressure medication (Image credit: FDA) The company hasn’t had any reports of users getting ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News losartan Source Type: news

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news

hydrochlorothiazide (Microzide, Hydrodiuril)
Title: hydrochlorothiazide (Microzide, Hydrodiuril)Category: MedicationsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 3/5/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - March 5, 2019 Category: Cardiology Source Type: news

losartan and hydrochlorothiazide (Hyzaar)
Title: losartan and hydrochlorothiazide (Hyzaar)Category: MedicationsCreated: 3/12/2000 12:00:00 AMLast Editorial Review: 3/4/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - March 4, 2019 Category: Cardiology Source Type: news

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news

Lowering BP, Lipids in Healthy Elderly Has No Cognitive Effect
WEDNESDAY, Feb. 27, 2019 -- Candesartan plus hydrochlorothiazide, rosuvastatin, or their combination do not impact cognitive decline among older people, according to a study published online Feb. 27 in Neurology. Jackie Bosch, Ph.D., from McMaster... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 27, 2019 Category: Pharmaceuticals Source Type: news

Another Drug Company Recalls Tainted Losartan Another Drug Company Recalls Tainted Losartan
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of losartan potassium and hydrochlorothiazide combination tablets owing to the presence of a probable carcinogen.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 27, 2019 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 25, 2019 Category: Food Science Source Type: news

Torrent Recalls Six More Lots of Tainted Losartan Tablets Torrent Recalls Six More Lots of Tainted Losartan Tablets
The company has recalled a total of 16 lots of losartan potassium and hydrochlorothiazide combination tablets because of the presence of a probable carcinogen.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 24, 2019 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 22, 2019 Category: Food Science Source Type: news

Heart Drug Recall Expanded Again
(CNN) — The recall of popular heart drugs has expanded yet again. The US Food and Drug Administration said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Losartan potassium is a drug used to control high blood pressure. It is also used to treat kidney disease in patients with diabetes. This recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets. Torrent is recalling only these particular losartan potassium tablets. Tests fou...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - January 4, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Recall Valsartan Source Type: news

Class 2 Medicines Recall: Actavis Group PTC EHF - recall of some batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets
Specific batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets, made by Actavis (now Accord), are being recalled as (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 3, 2019 Category: Drugs & Pharmacology Source Type: news

Mylan Expands Recall to All Unexpired Lots of Valsartan in US Mylan Expands Recall to All Unexpired Lots of Valsartan in US
The latest recall stems from NDEA contamination and includes 26 lots of amlodipine/valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan/hydrochlorothiazide tablets.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 7, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). (Source: Food a...
Source: Food and Drug Administration - December 4, 2018 Category: Food Science Source Type: news

Teva Recalls Two Blood Pressure Medications
FRIDAY, Nov. 30, 2018 -- All lots of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination blood pressure tablets have been recalled by Teva Pharmaceuticals due to higher-than-acceptable levels of a chemical that may cause... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 30, 2018 Category: Pharmaceuticals Source Type: news

Teva Recalls All Amlodipine/Valsartan Combination Products in US Teva Recalls All Amlodipine/Valsartan Combination Products in US
In the ongoing saga of tainted sartans, Teva recalls all amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination products because of contamination with NDEA.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 28, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan ’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, a...
Source: Food and Drug Administration - November 27, 2018 Category: Food Science Source Type: news

Mylan Recalls 15 Lots of Valsartan Products in US Mylan Recalls 15 Lots of Valsartan Products in US
The Mylan recall of valsartan tablets, amlodipine/valsartan tablets, and valsartan/hydrochlorothiazide tablets marks the latest recall of sartans contaminated with probable carcinogens.News Alerts (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 21, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in...
Source: Food and Drug Administration - November 21, 2018 Category: Food Science Source Type: news