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.
Category Archives: Food & Drug Recalls
Whole Foods Market Mid-Atlantic Region Recalls Tom Yom Soup Due to Undeclared Milk
Whole Foods Market Mid-Atlantic Region is recalling Tom Yom Soup because it contains milk, an undeclared allergen.
The recalled soup was sold with a Whole Foods Market scale label reading “Tom Yom Soup” with a UPC of in 24 ounce plastic containers with a “use by” date of 4/8/2014, which is noted on the scale label.
Med-Vet International Issues Nationwide Recall of Veterinary 1/2cc U-40 Insulin Syringes Due to Mismarked Syringe Barrels
On Feb. 14, 2014 , Med-Vet International initiated a nationwide recall of 140 boxes of 1/2cc U-40 insulin
syringes. The syringes have been found to be labeled with 40 units per 1/2cc syringe and they should be
marked with only 20 units per 1/2cc, which potentially could result in lower than prescribed doses of
insulin.
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. (“Fannie May�) 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.
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.
FDA approves Northera to treat neurogenic orthostatic hypotension
The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson’s disease, multiple-system atrophy, and pure autonomic failure.
FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs
The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.
MyNicKnaxs, LLC. Issues a Voluntary Nationwide and International Recall of All weight loss formulas of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction.
MyNicKnaxs, LLC., located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction because these products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both. At this time no illnesses or injuries have been reported to MyKnicKnaxs, LLC., in connection with these products.