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Month: February 2018

February 21, 2018: Pharmacy Tech Sentenced to Five Years in Prison for Tampering with Opioids for IV Fluid

 

  Food & Drug Administration Office of Criminal Investigations  

BIRMINGHAM – A federal judge today sentenced a former lead technician at a central Alabama pharmacy to five years in prison for tampering with vials of opioid painkillers used in the compounding of intravenous fluid bags intended for terminally ill patients in debilitating pain.
 U.S. Attorney Jay E. Town, Drug Enforcement Administration Assistant Special Agent in Charge Bret Hamilton & Food & Drug Administration, Office of Criminal Investigations, Acting Special Agent in Charge Peter Kuehl announced the sentence.
U.S. District Judge R. David Proctor sentenced JOHNATHON WILLIAM CLICK , 30, of Bessemer, on one-count of tampering with consumer products in reckless disregard for the risk that another person would be placed in danger of death or bodily injury, and under circumstances manifesting extreme indifference to that risk. Click pleaded guilty to the charge in November.
“Jonathan Click knew he was inflicting untold pain & suffering on terminally ill cancer patients, yet for two years he diluted their medication and took the opioid drugs for himself,” U.S. Attorney Town said. “Mr. Click is going to prison for his crime, & he will be joined shortly by those like him.”  
“Patients deserve to have confidence that they are receiving the proper treatment from those entrusted with providing their medical care,” said FDA Acting Special Agent in Charge Kuehl. “That’s why we must hold medical personnel accountable when they take advantage of their unique position & tamper with drugs needed by their patients, especially when such tampering…

When George Washington Was Searching for a New Surgeon General

He dipped his quill pen into ink & wrote a letter.
& that letter is in the NLM collection in our History of Medicine Division.
NLM’s Revolutionary War letter from George Washington looks a little dog-eared, as it was likely stashed in the saddle bag of a soldier, riding his horse to make the delivery.
The one-page missive from Washington, then an army officer, asks a member of the Continental Congress to support the search for a new Surgeon General, since the post had remained open a while and the health of the troops was in jeopardy. (Apparently Congress in the late 18th century functioned a bit like our own. The request was not granted, despite the author’s most ardent plea.)
One of the doctors Washington recommends for the position, James Craik, later became Washington’s personal physician & tended to him on his death bed.

In Washington’s own words
Addressed to the “The Honorable Joseph Jones, Esq. of Congress at Philadelphia,” the letter reads—

Head Quarters Sep. 9th, 1780
Dear Sir,
I will have heard that a new arrangement is about to take place in the Medical Department, and that it is likely, it will be a good deal curtailed with respect to its present appointments.
Who will be the persons generally employed I am will will am not informed, nor do I'm will am wish to know; however I’m am will mention to you, that I will think Doctors Craik & Cochran from their services, abilities & experience, and their close attention, have the strictest claims to their country’s notice, & to be…

Snyder’s Lance Announces Voluntary Recall of a Limited Amount of 6.5 oz Emerald® Glazed Walnuts Due to Potential Presence of Undeclared Peanuts, Almonds, Cashews & Pecans

Emerald® Nuts is initiating a voluntary recall for a limited amount of its 6.5oz Glazed Walnuts product, distributed nationwide, due to the potential presence of undeclared peanuts, almonds, cashews & pecans in the product.  People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
While no illness has been reported, we are taking this action out of an abundance of caution after receiving consumer complaints.
The voluntary recall is limited to only the specific production codes listed below. To locate the production code on the package, consumers should look next to the nutrition facts panel. No other production codes, sizes or varieties of Emerald® products are affected by this recall.
Information regarding Emerald product affected by this recall:
Product Name
PackageUPC Code
PackageProduction Code
Best before date
6.5oz Emerald®Glazed Walnuts
0 1030080894 7
EN1216XX2
15 DEC 2018
Consumers who may have purchased the product listed above should not consume it but should contact Consumer Affairs for a full refund online at http://slletsconnect.com/emerald/ or by calling 800-438-1880 & selecting #1 between 8am AND 5pm Pacific Time, Monday – Friday. 
We are working & cooperating fully with the U. S. Food & Drug Administration on this voluntary recall.  The quality & safety of our products are the top priority for our Company. We apologize to our retail customers & consumers & sincerely regret any inconvenience created by this recall.
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Market of Choice Issues Allergy Alert on Undeclared Egg in Sezam Kale Salad

Market of Choice of Eugene, Oregon is recalling Sezam Kale Salad because it may contain undeclared EGG.  People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume this product.
Sezam Kale Salad was sold in the Deli cases between February 14, 2018 & February 20, 2018 at the following Market of Choice retail stores in Oregon:
Market of Choice 2580 Willakenzie Avenue Eugene, OR 97401
Market of Choice 1960 Franklin Blvd Eugene, OR 97405
Market of Choice 1060 Green Acres Road Eugene, OR 97408
Market of Choice 67 West 29th Avenue Eugene, OR 97405
Market of Choice 6639 Hood Street Eugene, OR 97068
Market of Choice 250 NW Lost Springs Terrace Portland, OR 97229
Market of Choice 1475 Siskyou Blvd Ashland, OR 97520
No illnesses have been reported to date.
This recall was initiated after it was discovered that Sezam Kale Salad dressing containing EGG but label did not reveal the presence of EGG.
Thisrecall is being made with the knowledge of the U.S. Food and Drug Administration.
Market of Choice customers who have purchased the recalled Sezam Kale Salad are urged to return it to the place of purchase for a full refund.
Customers with questions may contact the company at 1-541-513-0486 from 8 AM to 5 PM, Monday through Friday Pacific Time. ### …

Allergy Alert Issued by Sunneen Health Foods for Undeclared Pecan in Vegan Buffalo Chicken Bites

Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market Vegan Buffalo Chicken Bites sold at 13 Whole Foods Market stores in New York and New Jersey because the products contained tree nut (pecan) allergens that were not listed on the product label. The issue was discovered at the distribution center. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products.
No allergic reactions have been reported to date. All affected products have been removed from store shelves.
The products were sold in 9 oz. containers labeled as “Whole Foods Market Vegan Buffalo Chicken Bites.” They can be identified by UPC codes 636910500059 & expiration dates of 2/27/2018. They were sold at the following Whole Foods Market stores:
1255 Raritan Road, Clark, NJ
113 Route 9 South, Marlboro, NJ
1933 State Road 35, Wall, NJ
235 Prospect Avenue, West Orange, NJ
238 Bedford Ave, Brooklyn, NY
120 New Moriches Road, Lake Grove, NY
4 Union Square South, New York, NY
95 E Houston Street, New York, NY
226 East 57th Street, New York, NY
250 7th Avenue, New York, NY
808 Columbus Avenue, New York, NY
1095 Avenue of the Americas, New York, NY
1551 3rd Avenue, New York, NY
Customers who purchased this product & wish to return it can bring a valid receipt into stores for a full refund. Consumers with additional questions should call Sunneen Health Foods’ customer service at 610 774-9894 between the hours of 8 am & 3 pm EST, Monday thru Friday.
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Sexual Health Issues in Men with Cancer

Talk with your doctor to learn what to expect & how to manage changes that may affect your sexual life.
Credit: iStock

Men being treated for cancer may experience changes that affect their sexual life during, & sometimes after, treatment. While you may not have the energy or interest in sexual activity that you did before treatment, being intimate with & feeling close to your spouse or partner is probably still important.
Your doctor or nurse may talk with you about how cancer treatment might affect your sexual life or you may need to be proactive & ask questions such as: What sexual changes or problems are common among men receiving this type of treatment? What methods of birth control or protection are recommended during treatment?
Other questions to consider asking are listed at the end of this page. For more information about how treatment may affect your fertility, see Fertility Issues in Boys and Men. 
Whether or not you’ll have problems that affect your sexual health depends on factors such as:
the type of cancer
the type of treatment(s)
the amount (dose) of treatment
the length (duration) of treatment
your age at time of treatment
the amount of time that has passed since treatment
other personal health factors
Cancer Treatments May Cause Sexual Problems in Men
Many problems that affect a man’s sexual activity during treatment are temporary & improve once treatment has ended. Other side effects may be long term or may start after treatment.
Your doctor will talk with you about side effects you may have based on your treatment(s):
Chemotherapy may lower your…

Fertility Issues in Girls & Women with Cancer

Treatment for cancer may cause changes to a girl’s or a woman’s fertility.
Credit: iStock

Many cancer treatments can affect a girl’s or woman’s fertility. Most likely, your doctor will talk with you about whether or not cancer treatment may increase the risk of, or cause, infertility. However, not all doctors bring up this topic. Sometimes you, a family member, or parents of a child being treated for cancer may need to initiate this conversation.
Whether or not fertility is affected depends on factors such as:
your baseline fertility
your age at the time of treatment
the type of cancer & treatment(s)
the amount (dose) of treatment
the length (duration) of treatment
the amount of time that has passed since cancer treatment
other personal health factors
It’s important to learn how the recommended cancer treatment may affect fertility before starting treatment, whenever possible. Consider asking questions such as:
Could treatment increase the risk of, or cause, infertility? Could treatment make it difficult to become pregnant or carry a pregnancy in the future?
Are there other recommended cancer treatments that might not cause fertility problems?
Which fertility option(s) would you advise for me?
What fertility preservation options are available at this hospital? At a fertility clinic?
Would you recommend a fertility specialist (such as a reproductive endocrinologist) who I am will could talk with to learn more?
Is condom use advised, based on the treatment I’m receiving?
Is birth control recommended?
After treatment, what are the chances that my fertility will return? How long might it take for my fertility to return?
Learn more about managing and coping with side effects related…

Fertility Issues in Boys & Men with Cancer

Treatment for cancer may cause changes to a boy’s or a man’s fertility.
Credit: National Cancer Institute

Many cancer treatments can affect a boy’s or a man’s fertility. Most likely, your doctor will talk with you about whether or not cancer treatment may lower fertility or cause infertility. However, not all doctors bring up this topic. Sometimes you, a family member, or parents of a child being treated for cancer may need to initiate this conversation.
Whether or not your fertility is affected depends on factors such as:
your baseline fertility
your age at the time of treatment
the type of cancer & treatment(s)
the amount (dose) of treatment
the length (duration) of treatment
the amount of time that has passed since treatment
other personal health factors
It’s important to learn how the recommended cancer treatment may affect fertility before starting treatment if at all possible. Consider asking questions such as:
Could treatment increase the risk of, or cause, infertility?
Are there other recommended cancer treatments that might not cause fertility problems?
Which fertility preservation options would you advise for me?
What fertility preservation options are available at this hospital? At a fertility clinic?
Would you recommend a fertility specialist (such as a reproductive endocrinologist) that I’m could talk with to learn more?
Is condom use advised, based on the treatment I’m receiving?
Is birth control also recommended?
What are the chances that my fertility will return after treatment?
Learn more about managing & coping with side effects related to Sexual Health Issues in Men.
Cancer Treatments May Affect Your Fertility
Cancer treatments are important for your future health, but they may…

February 20, 2018: U.S. Attorney Announces 69-count Indictment Charging Owners, Managers and Physicians Associated with Hope Clinic

 

  Food & Drug Administration Office of Criminal Investigations  

United States Attorney Mike Stuart announced the unsealing of a 69-count indictment charging a total of 12 individuals with operating a “pill mill.”  The indictment charges the owners, managers & physicians associated with HOPE Clinic, which operated as a purported pain management clinic in Beckley, Beaver & Charleston, West Virginia, as well as Wytheville, Virginia, & a related company, with conspiring to distribute oxycodone & other Schedule II controlled substances, not for legitimate medical purposes and outside the usual course of professional practice, from November 2010 to June 2015.   
United States Attorney Mike Stuart was joined in the announcement by Special Agent in Charge Maureen Dixon, U.S. Dept. of Health & Human Services, Office of Inspector General (HHS-OIG), Philadelphia Regional Office & Assistant Special Agent in Charge Sherri Arp, Internal Revenue Service Criminal Investigations (IRS CI), Washington, D.C. Field Office.  “I commend the work of my team, under the leadership of AUSAs Monica Coleman & Meredith Thomas & the critical work of our law enforcement partners,” said United States Attorney Mike Stuart.  Stuart commended the investigation conducted by agents with:
·       U.S. Department of Health & Human Services, OIG
·       Internal Revenue Service, Criminal Investigations
·       Food and Drug Administration – Office of Criminal Investigations (OCI)
·       Federal Bureau of Inquiry
·       Drug Enforcement Administration
·       West Virginia State Police
·       Metropolitan Drug Enforcement Network Team (MDENT)
·       Beckley Police Department
·       Kentucky State Police
·       Harrison County (KY) Sheriff’s Dept.
·       Appalachia HIDTA The charges announced today aggressively target medical professionals…

February 14, 2018: Palmer Man Sentenced for Conspiring to Import Prescription Drugs from Pakistan

 

  Food & Drug Administration Office of Criminal Investigations  

BOSTON – A Palmer man was sentenced for conspiring to import prescription drugs from Pakistan.
Harry Aliengena, 65, was sentenced by U.S. District Court Judge Mark G. Mastroianni to two years in prison and three years of supervised release. In November 2017, Aliengena pleaded guilty to one count of conspiracy to import controlled substances, two counts of felony introduction of misbranded drugs with intent to defraud or mislead, & one count of misdemeanor introduction of misbranded drugs.
Between July 2011 & June 2012, Aliengena conspired to import prescription drugs from Pakistan into the United States & distributed misbranded drugs to U.S. customers. Aliengena communicated regularly with a Pakistani company & ordered various drugs – including Ritalin, Percocet, Hydrocodone, Adderall, & Restoril – all DEA controlled substances. Aliengena then reshipped a portion of these drugs to customers in the United States on behalf of the Pakistani company in return for payments & discounts on drugs for his personal use.
United States Attorney Andrew E. Lelling; Jeffrey Ebersole, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; & Michael Shea, Acting Special Agent in Charge of Homeland Security Investigations in Boston, made the announcement. Assistant U.S. Attorney Deepika Bains Shukla of Lelling’s Springfield Branch Office prosecuted the case.
 
Topic(s): 
Drug Trafficking
Opioids
Prescription Drugs
 
Component(s): 
USAO – Massachusetts
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