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‘This will be remembered’
President Donald J. Trump hosted Israeli Prime Minister Benjamin Netanyahu for a bilateral visit at the White House yesterday. The two leaders discussed the imminent move of the U.S. Embassy in Israel to its capital city of Jerusalem, as well as the path to peace for the Middle East.
“I want to tell you that the Jewish people have a long memory,” Prime Minister Netanyahu said. “We remember 70 years ago, President Harry S. Truman was the first leader to recognize the Jewish state. And we remember how a few weeks ago, President Donald J. Trump recognized Jerusalem as Israel’s capital,” he continued.
“Mr. President, this will be remembered by our people throughout the ages. And as you just said, others talked about it. You did it.”
‘Needed attention’ on infrastructure
Two top officials in Oklahoma—the state’s Governor, Mary Fallin, along with Secretary of Transportation Mike Patterson—write that “infrastructure improvement is a priority issue because of its direct impact on economic growth and stability as well as the safety and well-being of our citizens.”
The two state leaders make a convincing case:
- In 2011, 706 of Oklahoma’s 6,800 highway bridges were structurally deficient. That number is coming down to 187 under Gov. Fallin, and the President’s “plan will allow Oklahoma to continue to prioritize infrastructure projects.”
- President Trump’s proposal includes traditional transportation such as roads and transit, but it also supports broadband internet, water and power systems, and other indispensable pieces for a modern infrastructure system.
- The Administration’s plan will benefit states such as Oklahoma by directing 25 percent of Federal funding—about $50 billion—for rural projects.
The bottom line? “We support the Trump administration’s infrastructure proposal for starting the dialogue about the need for these improvements,” the pair write.
America to overtake Russia on oil
The United States will eclipse Russia to become the largest oil producer in the world by 2023, The Wall Street Journal reported yesterday.
This latest headline is yet more evidence that President Trump’s plan to achieve American energy dominance is paying off just 13 months into his term. “Together, we are going to start a new energy revolution—one that celebrates American production on American soil,” the President said last year.
According to the Journal, “U.S. crude production is expected to reach a record of 12.1 million barrels a day in 2023, up about 2 million barrels a day from this year.” What will that mean for America? “Once heavily dependent on imports from the Middle East, the U.S. is getting closer to achieving its goal of producing enough crude to meet domestic demand for refined products like gasoline,” the Journal says.
PHOTO OF THE DAY
Vice President Mike Pence at AIPAC 2018 | March 5, 2018 (Official White House Photo by D. Myles Cullen)
POTUS TODAY
This afternoon, President Trump will participate in an expanded bilateral meeting with Prime Minister Stefan Löfven of Sweden. Later, the President will meet with Swedish business representatives before holding a joint press conference with Prime Minister Löfven. Watch live at 3:30pm ET.
This morning, the Vice President participated in a phone call with President Petro Poroshenko of Ukraine. The Vice President then travels to Omaha, Nebraska, to deliver keynote remarks at an America First Policies “Tax Cuts to Put America First” event.
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Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. This impurity has not yet been identified.
An elevated impurity has the potential to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.
Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results
AUDIENCE: Pharmacy, Risk Manager
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed in the recall notice. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. This impurity has not yet been identified.
An elevated impurity has the potential to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.
BACKGROUND: Methylprednisolone Sodium Succinate for Injection, USP is an anti-inflammatory glucocorticoid indicated for a number of conditions, including but not limited to: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, miscellaneous (trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy), neoplastic diseases, nervous system, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders. The product is supplied in 5 ml, 10 ml, and 30 ml glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018.
RECOMMENDATION: 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 lot 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.com.
Customers or consumers with 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 Methylprednisolone Sodium Succinate for Injection, USP may contact 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.
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 FDA Drug Safety Communication, at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm599663
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IDLife, LLC of Frisco, TX is voluntarily recalling its line of Protein Bars (Lot #s PR33471, PR31771, & PR31971), Snack Bars (Lot #s SN32071 & SN30771), and Kids Bars (Lot #s A3617-1 & 03047-1), because they may contain undeclared allergens. As part of its quality control review process, IDLife discovered that the lots of Protein Bars referenced above may contain undisclosed almonds, the lots of Snack Bars referenced above may contain undisclosed peanuts, and the lots of Kids Bars may contain undisclosed almonds and coconut oil. People who have an allergy or severe sensitivity to these specific allergens run the risk of serious or life-threatening allergic reaction if they consume these products.
The Bars were distributed nationwide through a direct to consumer distribution network
Kodiak Cakes Issues Allergy Alert on Undeclared Milk in Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz. Product UPC code is 7 05599 01215 0.
Kodiak Cakes of Park City, UT is recalling all lots and codes of Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz that were on shelf prior to March 5, 2018 because they 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.
The recalled frozen waffles were distributed nationwide to retail grocery stores. See attached picture to identify the retail packages of the product.
The improper labeling was discovered when a consumer notified Kodiak Cakes that a family member had a reaction to the product and that “milk” was not included in the allergen statement. While the specific ingredient “whey” is included in the ingredient declaration, the presence of milk is not identified in the ingredient list or declared in the allergen “contains” statement. To date, this complaint is the only report of injury or illness for this product due to the undeclared milk.
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