FDA

Articles that relate to FDA Activities

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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

Category: 

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”

Category: 

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.

Guixens Food Group Issues Allergy Alert on Undeclared Sulfites in La Marinera Brand Dried Yellow Potatoes

Category: 

Guixens Food Group, Inc., of Miami, FL, is voluntarily recalling its ten-ounce packages of La Marinera Brand Dried Yellow Potatoes because it may contain 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 this product.

The above-mentioned product was distributed to and available for purchase at retail supermarkets in Florida, Georgia, South Carolina, North Carolina, California, and Tennessee.

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

Category: 

ISSUE: NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product 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.

Voluntary Recall Notice of Happy Harvest Canned Spinach Due to Potential Undeclared Peanut Allergen from Product Mislabeling

Category: 

McCall Farms, Inc. is voluntarily recalling a limited amount of cases of Happy Harvest Spinach in 13.5 oz cans as a precautionary measure due to the potential presence of peanuts resulting from product mislabeling. This product may cause an allergic reaction in customers who have a peanut allergy.

In cooperation with ALDI, all affected product has been removed from its stores. ALDI is the only retailer with this product. The product was packaged in 13.5 oz cans with the lot code of A23IX. The best-by date is January 2021. The UPC code is 041498131289.

FDA Medwatch : Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

Category: 

AUDIENCE: Consumer, Pediatrics

ISSUE: MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. voluntarily recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution.

Pages

User login

CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.