Thyroid Tablets Recalled in US Because of Impurity Risk

Thyroid Tablets Recalled in US Because of Impurity Risk

Westminster Pharmaceuticals has recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level, according to a company notice posted on the US Food and Drug Administration (FDA) website. The recall is a precautionary measure because the products were manufactured using […]

US FDA flagged GMP concerns at valsartan maker's plants in two 483s

US FDA flagged GMP concerns at valsartan maker's plants in two 483s

Zhejiang Huahai Pharmaceutical has attracted regulatory attention worldwide since detecting a ‘probable carcinogen​’ impurity in its production of valsartan, an active pharmaceutical ingredient (API) used in heart medicines, last month. After initiating a recall of certain Zhejiang Huahai-made valsartan medicines, the US Food and Drug Administration (FDA) has published observations cited during two inspections at […]

FDA continues to expand recall for valsartan-containing products

FDA continues to expand recall for valsartan-containing products

On Aug. 9, FDA expanded its list of valsartan products currently under recall to include other items that contain the active ingredient, which may be tainted with a carcinogenic impurity, manufactured by Hetero Labs Limited in India. Certain valsartan products contain N-nitrosodimethylamine (NDMA), which is a known carcinogenic impurity. The FDA noted not all of […]

Global Active Pharmaceutical Ingredient Market Demand 2018- Dr. Reddy's Laboratories, Roche, Aurobindo pharma …

Global Active Pharmaceutical Ingredient Market Demand 2018- Dr. Reddy's Laboratories, Roche, Aurobindo pharma …

The global “Active Pharmaceutical Ingredient market” report provides a penetrating analysis of the Active Pharmaceutical Ingredient market. The report offers a concise outline of the market and describes the main terminologies of the market. The report has enclosed few of the prominent players in the global Active Pharmaceutical Ingredient market along with their share in […]

Active Pharmaceutical Ingredient Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2017 …

Active Pharmaceutical Ingredient Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2017 …

The Active Pharmaceutical Ingredient Market report provides a basic overview of the industry including definitions, classifications, Active Pharmaceutical Ingredient market by applications and industry chain structure. In this introductory section, the Active Pharmaceutical Ingredient Industry research report incorporates analysis of definitions, classifications, applications and industry chain structure. Besides this, the report also consists of development trends, competitive landscape analysis, […]

Valsartan-Containing Product Recall Expanded by FDA

Valsartan-Containing Product Recall Expanded by FDA

The ongoing Food and Drug Administration (FDA) product recall of valsartan-containing products now includes Camber Pharmaceuticals brands. On August 9, 2018, the FDA updated the list of valsartan products under recall and the list of valsartan products not under recall. This FDA update incorporates recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled […]

Concerns raised over recalled heart drug a year ago

Concerns raised over recalled heart drug a year ago

Mon, Aug 13, 2018 – 5:50 AM Washington A US inspector raised concerns with the Chinese manufacturer of a widely used heart drug more than a year before it was recalled for containing a probable cancer-causing chemical. A Food and Drug Administration inspection in May 2017 found that the company, Zhejiang Huahai Pharmaceutical Co Ltd, […]