FDA Alerts

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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Purina Animal Nutrition LLC Recalls One Lot of DuMOR Sheep Formula, 50 lbs. Bags Due to Potentially High Level of Copper; Distributed only in Florida

Purina Animal Nutrition LLC has initiated a limited voluntary recall of DuMOR Sheep Formula in Florida due to the potential for a higher-than-acceptable level of copper, which can cause health issues and potential mortality. There has been one report of sheep mortality associated with the single lot that is being recalled.

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Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility

Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

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Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Undeclared Milk and Yellow #5 in 8 in. Sundried Tomato, Spinach Pesto, and Chipotle Wraps

El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.

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