FDA MedWatch

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure

Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Expanded Recall of Dibar Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)

Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling all Dibar Labs Hand Sanitizer packaged in 8oz and 16 oz bottles, respectively, to the consumer level (see Label 1 below). Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2oz

Recall Expansion of Durisan Non-Alcohol Hand Sanitizer

Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary recall of Durisan Non Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Bu

Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde

Scentsational Soaps & Candles, Inc., has voluntarily expanded its April 27 recall of scented Hand Sanitizers to include three lots of Goose Creek HAND SANITIZER (NDC 75078-004) + Aloe and one lot of COCO TKO HAND SANITIZER in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer leve