FDA

Articles that relate to FDA Activities

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand

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Global Commodities, Inc. of Hicksville, NY is recalling 1lb and 0.5lb packages of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt, because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

The WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt was distributed from January 2015 to December 2017. The product was distributed at retail stores in New York State.

Divvies, LLC Conducts Voluntary Recall of Benjamint Crunch Chocolate Bars Due to Undeclared Milk In The Mint

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Divvies announced today a voluntary recall of its Benjamint Crunch Chocolate bars due to possible undeclared milk in the peppermint used in the bars. The recall is limited solely to the Benjamint Crunch Bars that were sold online through the Divvies website. This recall will impact approximately 140 consumers.

The product being recalled is the following:

H-E-B Voluntarily Issues a Precautionary Recall H-E-B Ode to Olives Sliced Salad Olives Being Recalled for Potential Glass in The Product

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Committed to the quality of its products, H-E-B is voluntarily issuing an all-store precautionary recall for H-E-B Ode to Olives Sliced Salad Olives in 10-ounce glass jars with a best by date of Nov. 3, 2019 due to the possible presence of glass in the product.

There have been no injuries reported due to this incident, which customers reported to H-E-B. All products related to this recall were sold at our Texas stores and have been removed from store shelves.

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

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Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

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ISSUE: AuroMedics Pharma is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

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ISSUE: FDA received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

BLM Issues Allergy Alert On Undeclared Egg and Milk

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BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg.

People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

In cooperation with ALDI, the affected product has been removed from its stores. ALDI is the only retailer with this product. The affected product was packaged in a 6.70 oz. glass jar with a multicolored printed paper label and a twist-off metal lid. The UPC code is 041498147631

A new MedWatch Safety Alert: Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

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ISSUE: Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.

Recall of Certain Lots of Izzy’s Maple Nut Ice Cream Due to Undeclared Peanuts

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Izzy’s Ice Cream, LLC is voluntarily recalling limited numbers of its Maple Nut Ice Cream pints following a supplier’s recall of walnuts due to the possible presence of undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products

Product Information

The products were produced on January 29th, 2018, February 6th, 2018, February 12th, 2018, February 19th, 2018 and February 27th, 2018 and can be identified by the following codes on the bottom of the pint:

Aspire Food Group Issues Alert on Undeclared Sulfites in Exo Bars

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Aspire Food Group of Austin, TX, is recalling its 60 gram bars of EXO Blueberry Vanilla, Peanut Butter & Jelly, and Apple Cinnamon bars because they may contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reaction if they consume these products.

The recalled EXO bars were distributed nationwide in retail stores and through mail orders.
The product comes in a film wrapper marked with the following lots/Best By dates on the underside of the wrapper.

Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk

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Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015.

Seabear Company Issues a Voluntary Recall of Cold Smoked Wild Coho Salmon Lox Because of Possible Health Risk

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Seabear Company of Anacortes, Washington is voluntarily recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand, affected lot # CSCO-17339, Pack Date 17-340, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Voluntary Recall of Certain Golden Flake, Good Health, UTZ and Weis Brand Tortilla Chips Because of Possible Milk Allergen

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Hanover, PA – Utz® Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk

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Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015.

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

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Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat and fish. People who have an allergy or severe sensitivity to these allergens may run the risk of a serious or life-threatening allergic reaction if they consume this product.

The recalled Four J Charred Tomato & Basil Sauce jars were only distributed in the state of Texas.

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