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 6, 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 and Drug Administration)
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 27, 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, and c...
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
Another Tainted'Sartan' Recalled for Impurity Another Tainted'Sartan' Recalled for Impurity
Sandoz, along with FDA, has recalled one lot of losartan potassium hydrochlorothiazide tablets because of the presence of the probable human carcinogen NDEA.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 16, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
MHRA Drug Safety Update: Hydrochlorothiazide: risk of non-melanoma skin cancer particularly in long-term use
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update: Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 15, 2018 Category: Drugs & Pharmacology Source Type: news
