Wolfgang B. Gourmet Foods, Inc. Issues Allergy Alert on Undeclared Fish (Anchovies) in Two Lots Of Fairway Brand Condiment Grilling Sauce

Wolfgang B. Gourmet Foods, Inc. of Catskill, NY, is voluntarily recalling approximately 236 units of FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT. 12 oz., UPC 758940706093, because it contains undeclared fish (anchovies). The Grilling Sauce is made with Worcestershire Sauce which contains anchovies as a sub-ingredient but anchovies are not listed on the label. People who are allergic to anchovies run the risk of a serious or life-threatening allergic reaction if they consume this product.

Evolution Fresh Voluntarily Recalls Select Bottles of “Organic Sweet Greens and Ginger” Juice Sold at California and Nevada Grocery Retailers

Evolution Fresh is initiating a voluntary product recall of approximately 1,700 bottles of “Organic Sweet Greens and Ginger” juice with a best by date of March 2, 2014. The juices, which make up less than half of one percent of total Evolution Fresh production, were sold beginning on January 18, 2014, only in California and Nevada at approximately 120 grocery stores.

Updated – Fannie May Issues A Voluntary Recall Of Its 4.0 Oz. Heart-shaped Box Of Assorted Chocolates Due To Undeclared Peanuts

Fannie May Confections Brands, Inc. is issuing the following update regarding its previously announced voluntary recall of red heart shaped boxes of assorted chocolates. The company initiated the voluntary recall on February 19, 2014. Fannie May Confections Brands, Inc. is recalling 12,000 units of its 4.0 oz., red heart-shaped gift box of assorted chocolates because the box includes one piece of candy that contains peanuts, a known allergen, and the food ingredient label on the box did not state that the product contained peanuts.

Falafel King Voluntarily Recalls Hatch Green Chile Hummus and Hatch Green Chile Wraps Because of Possible Health Risk

Falafel King of Boulder, Colorado is recalling 10 ounce containers of Hatch Green Chile Hummus and 8.5 ounce Hatch Green Chile Wraps because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new ‘cluster’ on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

Agila Specialties Private Limited Initiates Voluntary Nationwide Recall of 10 Lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL due to the Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date

PITTSBURGH, PA-Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (see lot breakdown below). The 10 lots were manufactured by Agila Specialties Polska sp.zo.o in Warsaw, Poland.

Philips Respironics Initiates Recall of Trilogy Ventilator

On February 11, 2014, Philips Respironics initiated a voluntary recall to address a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death.