FDA NEWS

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

June 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Rize 2 The Occasion Capsules, Rose 4 Her Capsules
UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil.

Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)
The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products.

Sodium Polystyrene Sulfonate Suspension
Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".

New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with...