A new MedWatch Safety Alert: Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

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ISSUE: Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepaciacomplex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error

ISSUE: Dräger Medical is recalling the Fabius Anesthesia machines due to excessive oil that was not removed at the time of production. Such excess oil may interfere with the position detector of the ventilation motor during operation and may cause ventilation to fail. A halt in ventilation may lead to serious adverse health consequences, including patient injury or death.

Model/Item Numbers: See complete lists for Fabius GS Premium, Fabius Tiro, Fabius Tiro M, Fabius MRI Anesthesia Machines

Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product

Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Piperacillin and Tazobactam For Injection 3.375 Grams Per Vial, Due to Presence of Glass Particulates

AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

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