PRESIDENT TRUMP'S WEEKLY ADDRESS

Military Leaders Visit The White House
Last night, President Donald J. Trump and First Lady Melania Trump welcomed senior military officials and their spouses to a dinner at the White House, during which they discussed the many challenges faced by military families.

Prior to dinner, the President participated in a briefing with the military leaders to review progress in protecting the homeland, advancing American prosperity, pursuing peace through strength, and promoting positive American influence abroad.

“America Will Return to the Moon – And Go Beyond”
On Wednesday, Vice President Mike Pence published an op-ed in The Wall Street Journal preceding the first meeting of the National Space Council in nearly 25 years. President Trump has revived the Space Council to assist his Administration in articulating and implementing long-term goals for the American space program. Two of those goals include re-establishing American presence on the moon and becoming the first Nation to bring mankind to Mars. At the Thursday morning meeting, Vice President Pence hearkened back to the early days of the American space program as the inspiration for renewing America’s competitive status in space exploration.

“The sight of Sputnik blinking across that October sky spurred America to action. We refused to accept a future in space written by the enemies of freedom, and so the United States of America vowed to claim our rightful place as the undisputed leader in the exploration of the heavens,” the Vice President said. “And twelve years later, with ‘one giant leap for mankind,’ America led in space…. We gather here today to renew this same mission in our time.”

See more from the first Space Meeting.

Hurricane Relief in Florida, Puerto Rico, and the U.S. Virgin IslandsVice President Mike Pence traveled to Florida on Thursday to receive a briefing on FEMA relief efforts following Hurricanes Irma and Maria and meet with individuals who have been impacted by the storms. FEMA also provided updates on Hurricane Maria in its daily briefing on Thursday morning. Key points included:

We continue to make progress through the unified efforts of the federal government, working hand-in-hand with Puerto Rico, its municipalities, businesses and voluntary agencies on the island.

Our goal is to help Puerto Ricans return to their routines, which will progress at a faster rate as more businesses open and communities are able to support their residents.

Although it will be some time before communities truly recover, residents are beginning to see some services being provided in their communities.

PHOTO OF THE DAY

President Trump meets with senior U.S. military leaders | October 5, 2017 (Official White House Photo by Joyce N. Boghosian)

POTUS AND VP TODAY

Today, President Trump and First Lady Melania Trump hosted an event at the White House honoring Hispanic Heritage Month. Later, the President signed a Proclamation declaring October 6th National Manufacturing Day.

Vice President Pence and Second Lady Karen Pence are in Puerto Rico and the U.S. Virgin Islands to survey hurricane recovery efforts and meet with individuals affected by the storms.

Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl sibutramine

Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.

These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to recall.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. To date, Kiriko, LLC. has not received any reports of adverse events related to this recall.

For additional information pertaining to this message, please click the link at the beginning of this

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

AUDIENCE: Risk Manager, Pharmacy

ISSUE: Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue. If accidentally frozen, INTRALIPID 20% IV Fat Emulsion should not be used. When subjected to freezing, the emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life-threatening.

BACKGROUND: INTRALIPID 20% IV Fat Emulsion is a prescription product indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of times. The product is packaged in 100 mL bags.

RECOMMENDATION: Baxter has informed customers affected by this particular shipment to locate and remove all affected product. 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.

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/ucm579386.htm

Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures

Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue.

If accidentally frozen, INTRALIPID 20% IV Fat Emulsion should not be used. When subjected to freezing, the emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life-threatening. To date, Baxter has not received any reports of associated adverse events or product complaints. INTRALIPID 20% IV Fat Emulsion is a prescription product indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of times. The product is packaged in 100 mL bags.