FDA Alerts

Hospira Issues A Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV Container Due to Particulate Matter

Hospira, Inc. (NYSE: HSP), announced today that it will initiate a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution.

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Maternal Science, Inc. Issues Allergy Alert on Undeclared Milk in healthy mama® Boost It Up!tm Mango Drink

Maternal Science, Inc. of Montvale, NJ, is voluntarily recalling healthy mama® Boost It Up!tm Drink because it contains undeclared milk (whey protein isolate). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Ateeco, Inc., Maker of Mrs. T’s Pierogies, Issues Voluntary Regional Product Recall of Mozzarella, Tomato & Basil Pierogies Due to Plastic Contamination

On February 27, 2015, Mrs. T’s Pierogies, of Shenandoah, PA, announced the voluntary recall of specific lots of its Mozzarella, Tomato & Basil variety of pierogies, due to safety concerns. The affected product was distributed to a limited number of retail customers and is being recalled due to plastic contamination in the product which may be a choke hazard.

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Talenti Gelato & Sorbetto Issues Allergy Alert for Limited Number of Jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato Due to Undeclared Peanut

Talenti Gelato & Sorbetto, a Unilever company, is voluntarily recalling a limited number of jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato because they may inadvertently contain peanuts (as peanut butter), which are not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

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Heartware International Recalls Certain Older Heartware Clinical Trial Controllers

HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012. HeartWare has commenced this field action in other countries in recent weeks.

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Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10).

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Fairway “Like No Other Market” Recalls Fairway Brand Raw Hazelnuts (Filberts) Because of Possible Health Risk

Fairway “Like No Other Market” of New York, NY, is recalling Fairway brand Raw Hazelnuts (Filberts), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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