Tuesday, June 21, 2016

FDA recalls some Nature Made vitamins

Pharmavite LLC is recalling some of their Nature Made products due to possible Salmonella or Staphylococcus aureus contamination.
The FDA issued the recall Wednesday and said they are working closely with Pharmavite. They are currently informing all of the company's retailers. 
Nature Made Adult Gummies Multi, Adult Gummies Multi + Omega-3, Adult Gummies Multi for Her plus Omega-3s and Super B Complex w with C and Folic Acid Tablets are affected by the recall.
Pharmavite believes the affected products are limited to specific lots. Lot numbers can be found on the back next to the expiration date. The recall was initiated after discovery that testing for Salmonella and Staphylococcus aureus were not completed properly on these products.
http://www.newspressnow.com/news/local_news/article_b498ce69-108f-538f-af4c-c7d1396be56c.html

Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns

Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration’s (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.
Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
All recalled products have a label that includes the name Well Care Compounding Pharmacy, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date.
We have not received any reports of adverse effects or injuries to date. We are conducting this recall after an inspection conducted by the FDA. Customers that have any recalled products should immediately stop using it and contact the pharmacy to arrange for the return of any unused product.

http://www.fda.gov/Safety/Recalls/ucm501543.htm

FDA Strengthens Warnings About Canagliflozin and Dapagliflozi

The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.
Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.
Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see Data Summary). This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys.
We urge health care professionals and patients to report side effects involving canagliflozin, dapagliflozin, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

http://www.fda.gov/Drugs/DrugSafety/ucm505860.htm

Thursday, April 21, 2016

Family of man killed in Turner Field fall sues Braves, MLB

I have nothing to do with this case, but it is an interesting read.The family of a man who from the upper deck at Turner Field filed suit Tuesday against the Atlanta Braves and Major League Baseball, claiming negligence relating to how high the guard railing should be. The lawsuit claims that the railing in front of Section 401 was only 30 inches high.

I have been in that area and while I may be a little bit apprehensive of heights, I do remember that the rails seemed lower than in other places.

http://www.myajc.com/news/news/family-of-man-killed-by-turner-field-fall-sues-bra/nq72B/  





Sunday, February 28, 2016

FATwater Recalled





FATwater,  which combines water with small amounts of XCT Oil, an ingredient sourced from coconuts and palm kernel oil has been recalled.

A recent FDA enforcement report found evidence of mircrobial growth in certain bottles. 

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=F-0575-2016&w=02172016&lang=eng

.

Monday, February 22, 2016

Pink Bikini, Shorts on the Beach Dietary Supplements Recall




An FDA analysis of Pink Bikini (white capsules, blue capsules and gold capsules) and Shorts on the Beach (blue capsules and gold capsules) found these products to be tainted with Sibutramine, Phenolphthalein, and/or Diclofenac, and that this active ingredients are not declared on the label of the product. 

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. Phenophthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the U.S. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). 

The use of diclofenac in patients already taking NSAIDS, with allergies, with underlying illnesses or with recent cardiac bypass surgery, could lead to gastrointestinal disturbances, fatal heart attack or stroke. Out of an abundance of caution, Lucy’s Weight Loss System is recommending that Pink Bikini and Shorts on the Beach, in all strengths and pill colors not be consumed, as they may contain any of these undeclared active pharmaceutical ingredients and/or an unknown active pharmaceutical ingredient. Any of these undeclared ingredients would make this product an unapproved new drug for which safety and efficacy have not been established.



http://www.infozine.com/news/stories/op/storiesView/sid/63799/

Thursday, February 18, 2016

FDA warns cannabis companies selling CBD supplements




News on the CBD front: In February 2016, FDA issued eight warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). FDA had previously issued six such letters in February 2015. FDA has tested these products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.










FirmProductStatePurchase WebsiteProduct Size
CBD Label Claim
Lab Results (mg/g)Lab Results %(w/w)
CBDΔ9-THCOther CannabinoidsCBDΔ9-THCOther Cannabinoids
Cali StoresCBDy CBD Supplement TinctureCAcalistores.com1oz
200mg CBD
--0.029THCA: 0.16--0.0029%THCA: 0.016%
Cali StoresHermosa Farm CannaHoney w/ CBD - 6ozCAcalistores.com6oz
N/A CBD
----THCA: <0 .01="" td="">----THCA: <0 .001="" td="">
Dose of NatureNano CBD Shooter *UThealthydoseofnature.com32 fl oz
1088mg CBD
0.22<0 .01="" td="">--0.022%0.001%--
Dose of NatureRed Strap Hemp Extract 250 – Coconut Oil *UThealthydoseofnature.com1fl oz
N/A CBD
5.60.033CBDA: 0.23
CBN: 0.106
0.56%0.033%CBDA: 0.023%
CBN: 0.0106%
Green Garden GoldCBD - Regular CBD-OilTXgreengardengold.com15ml
100mg CBD
0.790.02CBDA: <0 .01="" br="" style="box-sizing: border-box;">CBN: <0 .01="" td="">0.079%0.002%CBDA: <0 .001="" br="" style="box-sizing: border-box;">CBN: <0 .001="" td="">
Green Garden GoldCBD - Strawberry Jam CBD-OilTXgreengardengold.com6oz
N/A CBD
0.960.03CBDA: <0 .01="" br="" style="box-sizing: border-box;">CBN: <0 .01="" td="">0.096%0.003%CBDA: <0 .001="" br="" style="box-sizing: border-box;">CBN: <0 .001="" td="">
Healthy Hemp OilHerbal Renewals CBD Hemp Oil SupplementTXhealthyhempoil.com1oz
100mg CBD
2.40.081CBN: <0 .01="" td="">0.24%0.0081%CBN: <0 .001="" td="">
Healthy Hemp OilHerbal Renewals 25% CBD Hemp Oil Gold LabelTXhealthyhempoil.com3g
750mg CBD
2578.4CBN: 0.7025.7%0.84%CBN: 0.07%
Healthy Hemp OilPLUS+CBD Oil BalmTXhealthyhempoil.com1.3oz
N/A CBD
0.450.022CBDA: 0.90
THCA: 0.029
0.045%0.0022%CBDA: 0.09%
THCA: 0.0029%
Healthy Hemp OilHempotion Cannabidiol CBD ConcentrateTXhealthyhempoil.com.5oz
100mg CBD
6.60.21CBN: 0.0170.66%0.021%CBN: 0.0017%
Healthy Hemp OilEntourage Occam's RazorTXhealthyhempoil.com10ml
100mg CBD
6.8----0.68%----
Michigan Herbal Remedies, LLCBluebird Botanicals Bulletproof CBD BlendMImichiganherbalremedies.com1 fl oz
250mg CBD
8.70.35CBDA: 0.06
CBD: <0 .1="" td="">
0.87%0.035%CBDA: 0.006%
CBD: <0 .01="" td="">
Michigan Herbal Remedies, LLCUS Hemp Wholesale 25% CBD Hemp Oil Supplement Gold LabelMImichiganherbalremedies.com3g
750mg CBD
2448.6CBDA: 0.24
CBN: 0.8
24.4%0.86%CBDA: 0.024%
CBN: 0.08%
Michigan Herbal Remedies, LLCEndoca Hemp OilMImichiganherbalremedies.com10ml
15% CBD (1500mg)
1595.5CBDA: 10.2
THCA: 0.43
CBN: 0.47
15.90%0.55%CBDA: 1.02%
THCA: 0.043%
CBN: 0.047%
Michigan Herbal Remedies, LLCAlternate Vape LUV-A-BULLMImichiganherbalremedies.com10ml
100mg CBD
7.30.103CBDA: <0 .01="" br="" style="box-sizing: border-box;">CBN: 0.0110.73%0.0103%CBDA: <0 .001="" br="" style="box-sizing: border-box;">CBN: 0.0011%
Michigan Herbal Remedies, LLCTasty Hemp Oil - Tasty Drops Hemp Oil SupplementMItastyhempoil.com1 fl oz
250mg CBD
7.90.3CBN: 0.0240.79%0.03%CBN: 0.0024%
Michigan Herbal Remedies, LLCTasty Vape Hemp Oil - Just PeachyMImichiganherbalremedies.com10ml
100mg CBD
9.60.136CBDA: 0.015
CBN: 0.02
0.96%0.0136%CBDA: 0.0015%
CBN: 0.002%
Michigan Herbal Remedies, LLCPLUS+CBD Oil SprayMImichiganherbalremedies.com2 fl oz
N/A CBD
6.70.3CBN: 0.0240.67%0.03%CBN: 0.0024%
Morgue JuiceMorgue JuiceOK
TX
morguejuice.com150mg CBD0.23<0 .01="" td="">CBDA: <0 .1="" br="" style="box-sizing: border-box;">CBN: <0 .01="" td="">0.023%<0 .001="" td="">CBDA: <0 .01="" br="" style="box-sizing: border-box;">CBN: <0 .001="" td="">
PainBomb, LLCiHempCBD Filtered CBD Hemp OilUTpaindmso.com3g
35.51% - 25mg CBD/serving
3501.6CBN: 8.235.0%0.16%CBN: 0.82%
PainBomb, LLCPainBomb + CBDUTpaindmso.com2oz
N/A CBD
0.330.016--0.033%0.0016%--
Sana Te Premium OilsCBD Oil - 25.2% CBDCAetsy.com25mg/capsule
CBD
0.03117THCA: 0.08
CBN: 1.1
0.0031%1.7%THCA: 0.008%
CBN: 0.11%
25mg/capsule
CBD
0.06119THCA: 0.09
CBN: 1.2
0.0061%1.9%THCA: 0.009%
CBN: 0.12%
25mg/capsule
CBD
0.01713THCA: 0.06
CBN: 0.85
0.0017%1.3%THCA: 0.006%
CBN: 0.085%
* These products were not included in the Warning Letter due to changes to the firm’s website and/or product names
Abbreviations: Δ9-tetrahydrocannabinol (Δ9-THC), Cannabidiol (CBD), Cannabinol (CBN), Cannabidiolic Acid (CBDA), Tetrahydrocannabinolic acid (THCA)
Page Last Updated: 02/09/2016 

Monday, February 01, 2016

FDA Recalls Skinny Latina Million Dollar Marinade Over Undeclared Ingredient

New of a recent recall of Skinny Latina Million Dollar Marinade bottles from stores for containing undeclared soy. People who are allergic to soy should not consume the product.

The product is available in clear 12-ounce glass bottles with a label on the back stating when it is best consumed. All bottles with the label, “Best By 12-15-15” or earlier, are being recalled. The bottles did not include the corrected labels stating that these contain soy.
The recall was triggered by the discovery of soy in its gluten-free teriyaki sauce ingredient, without the packaging indicating its presence. It is important to note that Skinny Latina Foods Inc. voluntarily recalled the distributed products immediately after, the same press release states.
http://www.latinpost.com/articles/109995/20160120/fda-recalls-skinny-latina-million-dollar-marinade-over-undeclared-ingredient.htm


Tuesday, January 26, 2016

FDA recalls cough syrup brand, says it contains morphine -Master's Herbs Licorice Cough Liquid



According to the FDA: Consumers using this product may not be aware they are ingesting morphine. The unware ingestion of morphine can lead to life-threatening respiratory depression and death. Because the morphine contained in this product is not identified on the label there is a risk that patients who are hypersensitive to morphine could suffer severe allergic reactions. In addition young children with a respiratory illness are vulnerable to respiratory depression from opioids and should not be exposed to morphine in any event. To this date Master Herbs, Inc. is not aware of adverse events associated with use of the product.

Friday, January 15, 2016

Chipotle to close locations for national meeting on Feb. 8


Chipotle Mexican Grill will briefly close locations Feb. 8 when it hosts a national team meeting where the agenda will include food safety changes, a company spokesman said, in the wake of a series of norovirus and E. coli outbreaks that sickened dozens and drove down sales.

http://www.bostonglobe.com/business/2016/01/15/chipotle-close-locations-for-national-meeting-feb/5sXGhddM59MaKYrHWewHAO/story.html

Should Sugary Drinks have a Warning Label?

From CNN:

Bills are under consideration in New York and California that would require sugar-sweetened beverages to feature health warning labels on their packaging, similar to tobacco warning labels in the United States and many other countries. San Francisco has passed a law, which has not gone into effect yet, that requires advertisements for sugary drinks to include warning labels.
http://www.cnn.com/2016/01/14/health/warning-labels-sugary-drinks/

Bad idea- do you agree?

Thursday, January 14, 2016

FDA Issues Urgent Drug Recall of Certain Weight Loss Dietary Supplements - Trim Plus, Jenesis and Oasis

BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis and Oasis products from the market. Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", “Oasis”, and “Jenesis”.  The recall includes all lots and expiration dates.
BACKGROUND: Sibutramine and Phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It 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. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious, gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
RECOMMENDATION: Please determine if you have any of the above products on hand. If so, please discontinue selling the products and do not consume them. Please promptly dispose of all identified products. If you have further distributed La' Trim, Jenesis and/or Oasis, please contact your customers if possible and advise them of the recall situation. Provide them with a copy of this notice. Have them return their outstanding recalled stocks to you. If you have any questions regarding this recall please contact beextremellc@gmail.com or call 814-771-4377.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm478890.htm

Chromium Mineral Supplements May Cause Cancer: Other Health Risks Of Dietary Supplements

In a new study, Australian researchers discovered that chromium, which is commonly taken by bodybuilders and dieters, partiallyconverts into a carcinogen when it enters cells.

More at the link: http://www.techtimes.com/articles/123924/20160113/chromium-mineral-supplements-may-cause-cancer-other-health-risks-of-dietary-supplements.htm

Tuesday, January 12, 2016

R Thomas Marketing recalls numerous dietary supplements

R Thomas Marketing is recalling all lots of the following products:
  • Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)
  • Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Stree Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card / 48 capsules)
  • African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)
The products contain Sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels.

Additionally, the company is recalling all lots of the following products, which came from the same vendors as the above-mentioned products, and may contain Sildenafil:
  • Bull: CASE (10 packs / 3 capsules per can / 30 capsules)
  • Bulls Genital: CASE (10 Cans / 10 capsules per can / 100 capsules)
  • Zhonghua Niu Bian: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
  • African Superman: BIG BOX (6 small boxes / 8 capsules per box / 48 capsules)
  • Bigger Longer More Time More Sperms: BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules)
  • Black Ant King: BIG BOX (10 capsules / can / 12 cans per box / 120 capsules)
  • Black Storm: SMALL BOX (6 capsules)
  • Germany Niubian: BIG BOX (10 small boxes / 24 capsules per box / 240 capsules)
  • Happy Passengers: BIG BOX (30 small boxes / 1 capsule per box / 30 capsules)
  • Plant Vigra: BIG BOX / (18 cans / 6 capsules per can / 108 capsules)
  • Hard Ten Days: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
  • Man King: BIG BOX (8 small boxes / 5 capsules per box / 40 capsules)
  • Mojo Risen: BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules)
  • Night Man: SMALL BOX (6 capsules)
  • Tiger King: BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules)
  • Samurai-X: BIG BOX (24 individually wrapped capsules)
  • Super Hard: BIG BOX (20 small boxes / 6 capsules per box / 120 capsules)
  • Zhen Gong: BIG BOX (16 small boxes / 2 capsules per box / 32 capsules)
The above products were marketed as dietary supplements for male sexual enhancement, and were sold from September 2013 to the present mainly sold through the following websites:
The company is notifying its customers by directly via email.

Customers who have any of these above mentioned products should stop using them and arrange for return of them to: