Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.
Category Archives: Drug Safety Information Podcasts
FDA approves abuse-deterrent labeling for reformulated OxyContin
The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients.
FDA: U.S. Marshals seize food at New York-based food facility
U.S. Marshals have seized food products at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after investigators from the U.S. Food and Drug Administration found widespread rodent infestation in the facility.
FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety
The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food.
FDA approves Diclegis for pregnant women experiencing nausea and vomiting
The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
FDA approves Invokana to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Invokana (canaglifozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
FDA approves new multiple sclerosis treatment: Tecfidera
The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients
The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
FDA issues proposal to improve the quality of automated external defibrillators
The U.S. Food and Drug Administration (FDA) today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.