U.S.A.'s interesting latest..

Celebrate Earth Day Do you know the history of Earth Day? Read up on how the observance started. Hungry for more facts and figures about Earth Day and its impact? The Census Bureau has you covered with facts about energy, recycling, and resources.

Protection from ID Theft Did you know your child’s identity can be stolen? Check out this video to protect your child from ID theft. Don't hesitate when it comes to protecting your child's identity. Visit ftc.gov/idtheft for more information.

Resources for Military Child Month Check out these pages to find educational opportunities for military-connected children affected by mobility, family separation, and more.

How to Prepare for Emergencies Fred, the preparedness dog, is helping kids learn more about emergency readiness. Check out this video of Fred and how you can get the Fred APP. You can also learn more about Fred’s road to preparedness fame.

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You’ll get tips, suggestions, and advice, along with answers to your questions about benefits, planning, and more. To participate, click on our Facebook even link. For specific questions about your Social Security account and benefits, visit SSA.gov or contact your local Social Security office.  Join our event now!

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

AUDIENCE: Pharmacy, Patient

ISSUE: C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.

This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.

BACKGROUND: The product is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17. The 15 mg Tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30 mg Tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed Nationwide in the USA to Physician & Veterinarian Treatment Centers.

RECOMMENDATION: C.O. Truxton, Inc. is notifying all customers on record who purchased the affected product via US Mail which includes a recall letter, recall response form and is arranging for full credit returns, replacements, etc. of all recalled product. Consumers/distributors/retailers that have recalled product should stop using the product and return their product to their place of purchase.

Consumers with questions regarding this recall can contact C.O Truxton, Inc. by phone at (856) 933-2333, Monday to Friday between the hours of 9am and 5pm (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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online:www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554358.htm

H-E-B Voluntarily Issues a Precautionary Recall H-E-B and Hill Country Fare sandwich bread with a best buy date of April 29th or earlier being recalled for potential rubber in the product

04/21/2017 03:01 PM EDT

H-E-B, committed to the quality of its products, is voluntarily issuing a precautionary recall for H-E-B and Hill Country Fare sandwich bread with a best by date of April 29 or earlier due to the possible presence of a single piece of rubber in the product. This was an isolated incident. Bread purchased in the San Antonio area, Rio Grande Valley, Laredo and Corpus Christi stores is not impacted by this recall.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

What's New on the FDA Drugs Site

April 20, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
• National Drug Code Directory
• Use of Codeine and Tramadol Products in Breastfeeding Women - Questions and Answers (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• 11th Annual FDA/DIA Statistics Forum, April 24-26, 2017

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New and Generic Drug Approvals

 

April 20, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Botox  BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5302	Allergan	LABELING	Approved
Botox Cosmetic  BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5302	Allergan	LABELING	Approved
Clindamycin In 0.9%Sodium Chloride  NDA #208083	Clindamycin; Sodium Chloride	Injectable; Intravenous	ORIG-1	Celerity Pharms Llc	TYPE 5	Approved

April 19, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Cefuroxime Axetil  ANDA #065496	Cefuroxime Axetil	Tablet; Oral	SUPPL-6	Alkem Labs Ltd	MANUF (CMC)	Approved
Dabigatran Etexilate  ANDA #208057	Dabigatran Etexilate	Capsule; Oral	ORIG-1	Teva Pharms Usa		Tentative Approval
Dexlansoprazole  ANDA #202294	Dexlansoprazole	Capsule, Delayed Release; Oral	ORIG-1	Par Pharm Inc		Approved
Probuphine NDA #204442	Buprenorphine Hydrochloride	Implant; Implantation	SUPPL-3	Braeburn Pharms Inc	REMS	Approved
Xyrem  NDA #021196	Sodium Oxybate	Solution; Oral	SUPPL-26	Jazz Pharms	MANUF (CMC)	Approved

April 18, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Alendronate Sodium  ANDA #090258	Alendronate Sodium	Tablet; Oral	SUPPL-10	Austarpharma Llc	MANUF (CMC)	Approved
Cetylev  NDA #207916	Acetylcysteine	Tablet, Effervescent; Oral	SUPPL-3	Arbor Pharms Llc	LABELING	Approved
Dabigatran Etexilate  ANDA #207984	Dabigatran Etexilate	Capsule; Oral	ORIG-1	Glenmark Pharms Ltd		Tentative Approval
Eptifibatide  ANDA #204589	Eptifibatide	Injectable; Injection	ORIG-1	Akorn		Approved
Etomidate  ANDA #209058	Etomidate	Injectable; Injection	ORIG-1	Gland Pharma Ltd		Approved
Fluticasone Propionate  ANDA #077538	Fluticasone Propionate	Spray, Metered; Nasal	SUPPL-15	Apotex Inc	LABELING	Approved
Fluticasone Propionate  ANDA #077538	Fluticasone Propionate	Spray, Metered; Nasal	SUPPL-19	Apotex Inc	MANUF (CMC)	Approved
Glipizide  ANDA #075795	Glipizide	Tablet; Oral	SUPPL-13	Apotex	LABELING	Approved
Ibuprofen  ANDA #076925	Ibuprofen	Suspension; Oral	SUPPL-36	Perrigo R and D	LABELING	Approved
Lopid  NDA #018422	Gemfibrozil	Capsule; Oral	SUPPL-56	Pfizer Pharms	LABELING	Approved
Lopid  NDA #018422	Gemfibrozil	Tablet; Oral	SUPPL-56	Pfizer Pharms	LABELING	Approved
Montelukast Sodium  ANDA #209011	Montelukast Sodium	Tablet, Chewable; Oral	ORIG-1	Cspc Ouyi Pharm Co		Approved
Temozolomide  ANDA #203959	Temozolomide	Capsule; Oral	ORIG-1	Watson Labs Teva		Approved

 Απρ 21 τις 7:18 μ.μ.

Marketers of ‘NutriMost Ultimate Fat Loss System’ Settle FTC Charges The marketers of a weight-loss system advertised as using “breakthrough technology” and “personalized supplements” to help consumers permanently lose “20 to 40+ pounds in 40 days” without significantly cutting calories, have agreed to settle a Federal Trade Commission complaint that the claims were deceptive and not supported by scientific evidence. The court order settling the FTC’s charges bars the sellers of the “NutriMost Ultimate Fat Loss System” from making the deceptive claims alleged in the complaint, as well as providing others, including franchisees, with the means of deceiving consumers. The defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants, not from franchisees. According to the FTC’s complaint, since fall 2012, NutriMost, LLC; NutriMost Doctors, LLC; and their owner Raymond Wisniewski deceptively marketed the NutriMost weight-loss program to consumers. Sold at Wisniewski’s eight locations in the Pittsburgh area and by franchisees and licensees nationwide, the NutriMost System was marketed as using a new technology that would allow users to safely lose substantial amounts of weight – typically 20 to 40 pounds or more in 40 days. On their websites, on Facebook, and in traditional radio and newspaper ads, the defendants claimed the NutriMost System does not involve a restrictive diet, causes permanent weight loss, and helps users burn between 2,000 and 7,000 calories of fat per day. Claiming that the system would “Turn OFF fat storage and Turn ON fat burning,” the defendants charged consumers $1,895 for the program. The system was promoted, without appropriate support, as “having the technology to access nearly every factor of fat burning, fat storage and metabolism,” using a scan to address the “body’s top organ stressors, as well as find the best products to balance those . . . stressors.” What the defendants allegedly failed to say, however, was that to achieve the weight loss advertised, users would have to follow a restrictive diet, including a very low-calorie diet of about 500 calories a day. Only after they bought the system were consumers told of the extreme caloric restrictions, the FTC alleges. The complaint charges the defendants with using endorsements and testimonials for the system without disclosing that the endorsers had material connections to the defendants or their franchisees. The FTC also alleges that the defendants required buyers to sign a contract agreeing not to make any negative statements or comments about the NutriMost System, and that if consumers violated this requirement, they would have to pay the defendants $35,999. Finally, the defendants also allegedly provided program licensees and franchisees with the means to violate the FTC Act by giving them misleading and deceptive marketing materials, as well as the form contract containing the gag clause prohibiting negative reviews. The order settling the FTC’s complaint prohibits the defendants from making weight-loss and health claims unless they are not misleading and are supported with competent and reliable scientific evidence. It also bars the defendants from misrepresenting that users do not need to follow a restrictive diet. Next, it requires the defendants to disclose that their program includes a diet of less than 800 calories a day, if it does, and, if defendants make any representation regarding the safety of a program that includes a diet of less than 800 calories a day, then they must also disclose that physician monitoring is required to minimize the potential for health risks. The order prohibits the defendants from using deceptive endorsements in their marketing materials and from including non-disparagement clauses in their contracts. It also bars them from providing others with the means of making deceptive statements regarding weight-loss products or programs. Finally, it imposes a $32 million judgment against the defendants, which will be suspended based on defendants’ financial condition after they pay $2 million for consumer refunds. The Commission vote authorizing the staff to file the complaint and to approve the stipulated proposed order was 2-0. The FTC filed the complaint and proposed order in the U.S. District Court for the Western District of Pennsylvania. The FTC received assistance in investigating this case from Pittsburgh’s Better Business Bureau serving Western Pennsylvania. NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. Stipulated court orders have the force of law when approved and signed by the District Court judge. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.  Απρ 21 τις 6:18 μ.μ. FTC challenges bloated weight-loss claims By Seena Gressin Silence may be golden, but not when it comes to contract clauses that would muzzle consumer complaints. That’s one message from an FTC settlement with the makers of NutriMost weight-loss products. Here’s another: don’t make weight-loss claims without scientific evidence to back them. Read more > FTC Approves Final Consent Order with Online Company Charged with Deceptively Tracking Consumers Online and Through Mobile Devices Following a public comment period, the Federal Trade Commission has approved a final settlement with a Redwood City, California company over charges that it deceived consumers by tracking them online and through their mobile applications even after consumers took steps to opt out of such tracking. Turn Inc., which enables sellers to target digital advertisements to consumers, agreed in December 2016 to settle FTC charges that it misrepresented the extent to which it continued to track consumers even after they opted-out of such tracking. The company’s privacy policy told consumers they could block targeted advertising by using their web browser’s settings to block or limit cookies. The FTC’s complaint alleges, however, that Turn used unique identifiers to track tens of millions of Verizon Wireless customers, even after they blocked or deleted cookies from websites. The opt-out mechanism also only applied to mobile browsers. The FTC consent order bars Turn from misrepresenting the extent of its online tracking or the ability of users to limit or control the company’s use of their data. Turn also must provide an effective opt-out for consumers who do not want their information used for targeted advertising and place a prominent hyperlink on its home page that takes consumers to a disclosure explaining what information the company collects and uses for targeted advertising. The Commission vote approving the final consent order and letters to two commenters was 2-0. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357).  Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.