Arkansas Compounding Pharmacy Recalls Sterile Products

Flagged in recent inspections for apparent safety lapses, a compounding pharmacy in Conway, Arkansas, is voluntarily recalling all lots of its sterile products for humans and animals that were distributed between March 14, 2015, and September 9, 2015, the US Food and Drug Administration (FDA) announced today.

The pharmacy, US Compounding, is taking the action "due to (FDA) concern over a lack of sterility assurance," the company said in a news release posted on the agency's website.

The recalled products for humans — the vast majority are injectables — include testosterone, corticosteroids, glycopyrrolate, fentanyl, and the vasodilator alprostadil. Also on the list are topical ophthalmic drugs. The products were distributed to patients and healthcare providers alike.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

BeeXtreme Recalls All Lots of 3 Dietary Supplements

BeeXtreme LLC announced a recall of all lots of La' Trim Plus, Jenesis, and Oasis products from the market. A recent analysis by the Food and Drug Administration (FDA) had shown undeclared sibutramine and phenolphthalein in the Company's 3 dietary supplements.

Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake.

Lipo Escultura Corp. Issues Nationwide Recall of Lipo Escultura Due to Undeclared Sibutramine and Diclofenac

From the FDA:

Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp., and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the U.S. Food and Drug Administration and have been found to contain two potentially harmful ingredients--sibutramine and diclofenac.

Risk Statement: Sibutramine is an appetite suppressant now a controlled substance that was removed from the market for safety reasons. Sibutramine is known to 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. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDS may cause increased risk of cardiovascular events, such as heart attack and stroked, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

The product is used as a weight loss dietary supplement and is packaged in a white plastic bottle with green and lime labeling with white capsules. Products were sold/distributed Nationwide by JAT Productos Naturales Corp. via internet sales on www.lipoesculturatreatment.com, through Lipo Escultura Corp. 888 Wyckoff Ave. Brooklyn, NY 11237, a retail store and 1360 Hancock Street, Brooklyn, NY 11237, a home office.

The recall was initiated after a consumer illness was reported to the FDA and it was discovered that the product labeling does not reveal the presence of sibutramine or diclofenac.

http://www.fda.gov/Safety/Recalls/ucm475550.htm

Legal: Florida Company Glades Drugs Recalls Multivitamins Recalled for High Vitamin D3

News out of Pahokee this past week. 

The FDA announces a  voluntary recall of compounded multivitamin capsules that have high amounts of Vitamin D3 (Cholecalciferol). The product was distributed nationwide by Glades Drugs in Pahokee, Florida. The FDA has received several reports of adverse reactions that may be associated with this recalled product.

From the FDA site: 

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol),  distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.

BACKGROUND: Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.

RECOMMENDATION: Health care providers should quarantine and return any products subject to this recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.  Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.

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:

Lucy's Weight Loss Recalls Pink Bikini White Powder Capsules

Lucy's Weight Loss System has voluntarily recalled all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level, as it has been found positive for diclofenac after FDA sampling and testing.

Pink Bikini is marketed as a weight loss dietary supplement and is packaged in clear bottle in white powder capsules. The product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.

Diclofenac is a nonsteroidal anti-inflammatory drug or NSAID. This medicine works by reducing substances in the body that cause pain and inflammation.

Diclofenac can increase the risk of fatal heart attack or stroke, especially if used long term or taken high doses, or if the user has heart disease.

For pregnant women, taking diclofenac during the last three months of pregnancy may harm the unborn baby.

This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established.

Lucy's Weight Loss System has not received any reports of adverse events related to this recall.

http://www.rttnews.com/2589876/lucy-s-weight-loss-recalls-pink-bikini-white-powder-capsules.aspx

Boston Scientific recalls Chariot Guiding Sheaths, citing complications

Boston Scientific Corp.’s Maple Grove campus is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow.

The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to make sure they’re doing OK.

More here: http://www.startribune.com/boston-scientific-recalls-chariot-guiding-sheaths-citing-complications/361361441/

Chipotle ecoli outbreak in Georgia, November 2015

Folks across Atlanta and beyond are asking about the supposed outbreak. Here is what we know: 


From the FDA:  

• Three additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update, Illinois, Maryland, and Pennsylvania.
• Fifty-two people infected with the outbreak strain of STEC O26 have now been reported from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).
• The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.
• The investigation is still ongoing to determine what specific food is linked to illness.

As of December 4, 2015, the The CDC says that a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27). There have been 20 reported hospitalizations. 

Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began.

What are the Signs & Symptoms of E. coli O26?

• People usually get sick from STEC (Shiga toxin-producing E. coli) 2-8 days (average of 3-4 days) after swallowing the organism (germ).
  • Most people infected with STEC develop diarrhea (often bloody) and abdominal cramps.
  • Most people recover within a week.
• Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS).
  • HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.
  • Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination.
  • People who experience these symptoms should seek emergency medical care immediately.
• STEC infection is usually diagnosed by testing of a stool sample for Shiga toxins.
• Clinical laboratories are required in some states to send Shiga toxin-positive specimens from ill people to the state public health laboratory for identification of STEC and PulseNet testing.

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm470410.htm