Tag Archives: FDA

Kraft Foods Group Voluntarily Recalls Select Kraft Macaroni & Cheese Boxed Dinners Due to Possible Metal Pieces

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ucm438726NORTHFIELD, Ill. — Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal. The recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to a specific production line on which the affected product was made.

Some of these products have also been packed in multi-pack units that have a range of different code dates and manufacturing codes on the external packaging (box or shrink-wrap), depending on the package configuration (see table below).

Recalled product was shipped to customers in the U.S. and several other countries, excluding Canada. The affected dates of this product were sold in only these four configurations:

  • 7.25 oz. box, Original flavor
  • 3-pack box of those 7.25 oz. boxes, Original flavor
  • 4-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
  • 5-pack shrink-wrap of those 7.25 oz. boxes, Original flavor

The following is being recalled:

Product Size Name of Product Sell Unit Best When Used By Code Date & Mfr. Code Individual Box Best When Used By Code Date & Mfr. Code Individual Box UPC Multi-Pack Unit UPC
7.25 oz. each Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 NA 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 NA
3-Pack Box
(Three 7.25 oz. Boxes)
Net Wt. 21.75 oz.		 3-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 09 SEP 2015 XDG
27 SEP 2015 XDG
01 OCT 2015 XDG
02 OCT 2015 XDG
03 OCT 2015 XDG
20 NOV 2015 XDG		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 05076 5
4-Pack
Shrink–wrap
(Four 7.25 oz. Boxes)
Net Wt. 29 oz.		 4-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015 C2
19 SEP 2015 C2
08 OCT 2015 C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 72540 3
5-Pack
Shrink-wrap
(Five 7.25 oz. Boxes)
Net Wt. 36.25 oz.		 5-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015
through
11 OCT 2015
XAR or C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 77436 4

No other sizes, varieties or pasta shapes and no other packaging configurations are included in this recall. And no products with manufacturing codes other than “C2” below the code date on the individual box are included in this recall.

Kraft has received eight consumer contacts about this product from the impacted line within this range of code dates and no injuries have been reported. We deeply regret this situation and apologize to any consumers we have disappointed.

The recalled product was shipped by Kraft to customers nationwide in the U.S. The product was also distributed to Puerto Rico and some Caribbean and South American countries — but not to Canada.

Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-816-9432 between 9 am and 6 pm (Eastern) for a full refund.

Frontier Co-op Initiates Voluntary Class 1 Recall Due to Possible Health Risk from Organic Garlic Powder

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recall-3Frontier Co-op is voluntarily recalling several of its products manufactured with organic garlic powder that were sold under its Frontier and Simply Organic brands, and one product sold under the Whole Foods Market brand due to potential Salmonella contamination. To date, no illnesses have been associated with these products.

The product in question was raw material received by Frontier, which tested positive for Salmonella during a test by the United States Food and Drug Administration. Given that Salmonella may be present, Frontier is immediately initiating this recall.

Frontier Co-op is immediately initiating added precautions to the safety of the supply chain and instituting additional product testing, beyond FDA guidelines, to mitigate any future occurrence.

Consumption of products containing Salmonella 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, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditic and arthritis.

Recalled products were sold in all 50 states and in some parts of Canada to distributors, retailers and consumers. Below the release is a list of products containing the organic garlic powder. Images of the affected products can be viewed at the following link: http://www.frontiercoop.com/recalldisclaimer icon.

On foil bulk packages, the four-digit lot code will be found on the front label directly above the UPC code. On bottled items, the four-digit lot code can be found on the bottom of the bottle. On seasoning mixes, the four-digit lot code is embossed on the right side of the packet.

Consumers should not consume these products and should either throw away any remaining products or return to the point of purchase for a refund.

Please contact Frontier Co-op with any questions or to inquire about replacement or reimbursement at 1- 800-669-3275 Monday through Friday from 8:00 a.m. to 5:00 p.m. Central time.
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Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection

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FDA-Recall-MedSchaumburg, ILLINOIS – 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. Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall.

Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers being recalled are VATA012, VATA015 (50mg/5mL) and VATB012, VATB013, VATB014, VATB017 (100mg/10mL) which were distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015. Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.comdisclaimer icon.

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Atracurium Besylate Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements

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dextrol-recallDetox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.

Product Name Bottle Color Label # Capsules UPC Lot Expiration
EDGE Amplified Weight Release White Purple label 60 852175004174 ALL
iNDiGO White Dark blue label 60 852175004044 000034 4/10/2017
AMPD Gold Bee Pollen White Black label 60 852175004181 ALL
BtRim Max White Dark Red label 60 852175004068 00002 4/27/2017
iNSANE Bee Pollen White Bright Red label 60 852175004082 0000:02 6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Fluoxetine is an SSRI with potentially life-threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores. No illnesses have been reported to date with the use of these products.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recent food recalls by the FDA

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salmonellaThree food companies issued recalls this month; the most recent nSpired Natural Foods. The food products were recalled because of salmonella risks.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.

The recall effects nSpired peanut and almond butters, McCormick oregano and Sunfood Carob powder.
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Walnuts Are Drugs, Says FDA

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The real dangerous nuts come in JC Penny three-piece suits.

This is an example of an agency completely out of control abusing their unconstitutional authority, if true. Do you feel safe now?

by MICHAEL TENNANT

Shelled_walnutsSeen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

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