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FDA Alerts

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death. 6/23/2017 11:31:00 PM

Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product. 6/23/2017 7:49:00 PM

Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents. 6/23/2017 4:09:00 PM

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. 6/22/2017 7:35:00 PM

H-E-B, committed to the quality of its products, is issuing a recall for H-E-B Creamy Creations Cherry Vanilla Light Churn Style Half-Gallon Ice Cream from five potentially impacted stores because it may contain an undeclared nut allergen. There have been no reported illnesses related to this recall. 6/21/2017 3:04:00 PM

JFC International Inc. of Los Angeles, CA is voluntarily recalling a rice seasoning product because it was found to be missing the English Product Label for sale in the United States. In addition, due to the missing English label, the product has undeclared Wheat, Soybean, and Fish (Bonito) allergens. People who have allergies to wheat, soybeans, or fish (bonito) run the risk of a serious life-threatening allergic reaction if they consume the product. No illnesses have been reported to date in connection with this problem. 6/21/2017 12:39:00 AM

United Natural Trading LLC, Edison, NJ, is voluntarily recalling a limited number of products containing Organic and Natural dates (see below) and sold under the Nature’s Promise, Woodstock, Market Basket, and Wholesome Pantry brands due to a possible health risk from Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune symptoms. 6/20/2017 8:03:00 PM

A single production batch of Fat Cat Purry-Purry Sauce Hot Sauce, sold specifically to Winn-Dixie Supermarkets, BI-LO Supermarkets and Harvey’s Supermarkets in the Southeastern U.S., has been recalled due to a potential peanut contamination found in the product. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. 6/20/2017 7:01:00 PM

House of Thaller, a Knoxville Tennessee company, is voluntarily recalling selected 10 ounce packages of Hummus with Pine Nut Topping, because an ingredient supplier notified us that their ingredient has the potential to be contaminated with Listeria monocytogenes. 6/20/2017 3:05:00 PM

Hampton Farms is expanding its voluntary recall to include Ava’s Brand Organic Roasted Unsalted Cashews and Ava’s Brand Organic Roasted Unsalted Almonds distributed only in New Jersey. This is the result of a recall expansion from Hampton Farms’ supplier, Hudson Valley Foods, Inc. of Highland, NY advising Hampton Farms that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes. 6/20/2017 2:22:00 PM

Kabir’s Bakery of Brooklyn, NY is recalling “Kabir’s Bakery Cinnamon Twist“ and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes, due to the presence of undeclared milk. Consumers who are allergic to milk run the risk of serious life threatening allergic reactions if they consume this product 6/19/2017 7:38:00 PM

Rikki USA, Inc. of Redmond, WA is recalling Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce because it contains undeclared milk. 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. 6/19/2017 7:17:00 PM

Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code. 6/19/2017 12:56:00 PM

On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall. 6/17/2017 10:35:00 PM

Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company. 6/17/2017 12:07:00 AM

Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. 6/16/2017 11:26:00 AM

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection which would lead to a lower dose being administered. 6/15/2017 9:53:00 PM

Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the CONSUMER/USER level. 6/15/2017 6:09:00 PM

Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years. 6/14/2017 6:42:00 PM

Bristol-Myers Squibb Company (NYSE: BMY) is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. 6/13/2017 4:25:00 PM

Giant Eagle, Inc. has announced a voluntary recall of Market District Toasted Crumb Tilapia and Giant Eagle Toasted Crumb Tilapia sold fresh from the seafood department of its supermarkets, and Giant Eagle Breaded Chicken Breast sold in the prepared foods department, due to an undeclared milk allergen. People who have an allergy, or severe sensitivity to milk, may experience serious or life-threatening allergic reactions if they consume these products. 6/12/2017 10:30:00 PM

Slade Gorton, Boston, MA is recalling the following products because they may contain undeclared milk. 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. 6/12/2017 5:21:00 PM

Naturally Wholesome Products LLC is voluntarily recalling gallon and pint containers of Half & Half labeled under the brand name Wholesome Country Creamery due to the presence of Alkaline Phosphatase found in samples during routine testing. Naturally Wholesome Products LLC has received no reports of illnesses related to the affected product and is removing the product from the market out of the abundance of caution. 6/5/2017 4:35:00 PM

In collaboration with the U.S. Food and Drug Administration (FDA), Smucker Foods of Canada Corp. today announced a voluntary recall on specific production codes of Golden Temple®, Swad®, and Maya® flour products in the U.S. due to possible E. coli O121 contamination. 5/31/2017 3:45:00 PM

Baltimore, Maryland, Lupin Pharmaceuticals Inc. announced today that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. 5/29/2017 2:22:00 PM

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