• In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration (“FDA”) to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. To date, Flawless Beauty has not received any reports of adverse events related to this recall.

  The following products are subject to the recall and were sold and distributed over the Internet to U.S. and foreign customers. The web site of Flawless Beauty is www.flawlessbeautyandskin.com. All glutathione products were sold in multi-vial whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules of vitamin C or sterile water purchased separately or as part of these whitening kits are also recalled:

  Flawless Beauty is notifying its customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty.

  Consumers with questions regarding this recall can contact Flawless Beauty by phone at 1-917-831-5948 or jack@flawlessbeautyandskin.com on Monday-Friday, 9:30AM – 5:30 PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

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

  • Complete and submit the report Online: www.fda.gov/medwatch/report.html
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.html or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

  This recall is being made with the knowledge of the Food and Drug Administration.

• Break Ventures/California Basics is recalling its Dietary Supplement “Zero for Him 150ct” Lot#1710-638 (the “Product”) because it may 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

  The Product was distributed nationwide through Amazon. It comes in a 400cc, Light Amber PETE bottle marked with lot #1710-638 on the bottom and with an expiration date of November 2020 stamped on the side.

  No illnesses have been reported to date in connection with the Product.

  The potential for contamination was noted after routine testing by the company revealed the presence of Salmonellain 1 bottle. We have tested and re-tested the Product and no presence of Salmonellawas subsequently found. However, out of abundance of caution, we have decided to recall this Product.

  Distribution of the Product has been suspended while FDA and the company continue their investigation as to the source of the Salmonellapresentin that aforementioned 1 bottle.

  Consumers who have purchased Zero for Him Lot#1710-638 are urged to return them to the place of purchase for a full refund. Consumers with additional questions may contact the company at 323-375-5953.

• Norovirus – El Toro and Pho aroma – Seattle,WA
• Café Spice GCT Inc., Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding and an Undeclared Allergen
  Café Spice GCT Inc., a New Windsor, N.Y. establishment, is recalling approximately 289 pounds of chicken salad products due to misbranding and an undeclared allergen.
• Duke Sandwich Productions, Inc. Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding
  Duke Sandwich Productions, Inc., an Easley, S.C. establishment, is recalling approximately 743 pounds of chicken salad products due to misbranding
• Evershing International Trading Company is recalling Coconut Tree Brand Frozen Shredded Coconut, 16 oz., because they have 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 system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.This coconut product was distributed in Ohio, Massachusetts, Washington, California, and Oklahoma with redistribution to Illinois, Michigan, New Jersey, New York Pennsylvania, Oregon, Florida, and Texas. This Frozen Shredded Coconut product is packaged in 16 ounces plastic bags. This is a complete recall of ALL Coconut Tree Brand Frozen Shredded Coconut currently on the market. Any customers who have this product should return the product to place of purchase for full refund. Customers may also contact Evershing International Trading Company at (408) 975-9660 during hours of operation, Monday to Saturday from 9:00 am to 5:00 pm.The issue was discovered by testing performed by the State of Massachusetts.This voluntary recall is being made with the knowledge of the US Food and Drug Administration. We appreciate your assistance in this matter.
• 

Palmer Candy Company (www.palmercandy.com), announced today a limited recall of Sea Salt Caramel Hearts that were only sold at Bomgaars Supply Inc. Store in the Midwest States. The voluntary recall, in cooperation with the U.S. Food and Drug Administration (FDA) due to abundance of caution of a possible peanut allergen contamination. 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.

The issue was discovered by Palmer Candy Team Members. During the packing process a peanut was observed stuck to the outside of the Sea Salt Caramel Heart. To date no complaints of illness or injury have been reported to Palmer Candy.

UPC #s are usually on the label on the bottom of containers. The Best Buy Date is on the bottom of the containers.

Product photos are attached.

Product was sold in IA, SD, NE, MN, WY, CO.

Consumers should throw out or return these products to the point of sale for a full refund. For more information, consumers may call to speak with a Customer Service Representative at Palmer Candy Company between 9:00 a.m. and 4:30 p.m. Central Standard Time at 712-258-5543.

• AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.Risk Statement: Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the specified conditions. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). The affected Levofloxacin in 5% Dextrose Injection 250mg/50mL lot being recalled is CLF160003, Expiry date May 2018. This recall is being carried out to the hospital level. It is packaged in a carton containing 24 bags, NDC: 55150-243-46. The product can be identified as a single-use, ready-to-use flexible plastic infusion bag in a foil laminate overwrap. AuroMedics shipped the lot to wholesalers and/or hospitals nationwide September 19 through October 31, 2017.AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.

  Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952, Monday through Friday from 8:30 AM to 5:00 PM EST. 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 the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htmor call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail user level. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8 a.m. and 5 p.m. Central Time. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

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

  Complete and submit the report Online: www.fda.gov/medwatch/report.htmRegular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.