Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results

Our office is investigating this recall, 866-373-1800: 

Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) listed in the table below, to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico.

Hyoscyamine Sulfate 0.125 mg Recalled Batches
Form	NDC	Package Size	Batch #	Expiry
Sublingual Tablets	76439-309-10	100-count	30051601	Jan-18
			30051602	Jan-18  Jan-28*
			30051603	Jan-18
			30051604	Jan-18
Oral Disintegrating Tablets	76439-307-10	100-count	30011601	Jan-18
Tablets	76439-308-10	100-count	30031601	Jan-18
			30031602	Jan-18

*A small number  of bottles from this lot have  the incorrect expiration date  printed on them.

Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures. The severity of the adverse event would depend on how superpotent the tablet was. Adverse events such as clotted blood within the tissues and fractures could occur, as a result of falls from dizziness or seizures if the strength is particularly high. To date, Virtus has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. These symptoms were reported to be resolved are all believed to be temporary. None of the adverse events were life threatening, and the patients who reported the incidents were treated and released.

Hyoscyamine sulfate is an anticholinergic agent which blocks the action of acetylcholine and is used to treat diseases like asthma, incontinence, stomach cramps, peptic ulcers, control gastric secretion, intestinal spasm and other bowel disturbances. These products were distributed Nationwide in the U.S. and Puerto Rico starting on March 11, 2016, to distributors, hospitals, and retail pharmacies.

Virtus is notifying its distributors and retailers by letter and email and is arranging for return of all recalled drug product. Consumers, distributors, and retailers that have the hyoscyamine sulfate product lots listed above should stop using/distributing and return to place of purchase.

Consumers with questions regarding this recall can contact Virtus at 1-855-255-6076 on Monday through Friday from 8 am to 5 pm EST or rxrecalls@inmar.com.Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Virtus

Virtus Pharmaceuticals is a specialty niche pharmaceutical company focused on the development and marketing of prescription products to pharmaceutical wholesalers, distributors and retailers across the United States. Virtus offers its customers a diversified product portfolio covering a broad range of therapeutic areas, including prenatal vitamins, women’s health, vitamin supplements, anti- bacterials, and others, in a variety of dosage forms. Virtus is headquartered in Tampa, FL.

Teething tablets may be linked to 10 children's deaths, FDA says

News this week regarding homeopathic products for babies. 

While there is no recall on the products, including Hyland's Baby Teething Tablets, Hyland's Baby Teething Tablets Nighttime and Hyland's Baby Teething Gel. CVS, one of the drugstore chains that sold Hyland's, Baby Orajel Naturals and its own version of the teething products, stores have pulled all of them from shelves after an FDA warning. Walgreens also confirmed that it has withdrawn homeopathic teething products that were subject to this FDA warning, below. Talk to us about this if you are concerned your child may have been harmed by calling Toll Free (855) 525-3955

From the FDA site:

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program.

NOTE: We can't help everyone, and our law licenses in the office are lim  

Teething tablets may be linked to 10 children's deaths, FDA says

News this week regarding homeopathic products for babies. 

While there is no recall on the products, including Hyland's Baby Teething Tablets, Hyland's Baby Teething Tablets Nighttime and Hyland's Baby Teething Gel. CVS, one of the drugstore chains that sold Hyland's, Baby Orajel Naturals and its own version of the teething products, stores have pulled all of them from shelves after an FDA warning. Walgreens also confirmed that it has withdrawn homeopathic teething products that were subject to this FDA warning, below. Talk to us about this if you are concerned your child may have been harmed: 

From the FDA site:

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:

Cookie Dough Recall Hits Ice Cream

Aspen Hills, the supplier of the cookie dough pieces used as an ingredient in the Publix Chocolate Cookie Dough Ice Cream, notified Publix that some of their product could be contaminated with Listeria monocytogenes. Publix Super Markets is issuing a voluntary recall for Publix Premium Chocolate Chip Cookie Dough Ice Cream due to the possibility of the product containing Listeria monocytogenes.

The ice cream was sold at Publix stores in Florida, Georgia, Alabama, South Carolina, Tennessee and North Carolina with a UPC of 000-41415-03843, and a sell by date of May 27 2017, which is printed on the bottom of the half gallon container.

Listeria monocytogenes is a bacteria that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

http://www.fda.gov/Safety/Recalls/ucm524880.htm

FDA: Some Drumstick ice cream cones recalled for possible Listeria contamination

Nestlé USA, Inc. is initiating a voluntary recall of its Nestlé Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to a possible health risk. The two pack sizes contain 4.6 fl.oz. cones and were manufactured in Bakersfield, Calif. and distributed nationally. No other production codes, sizes or varieties of Nestlé Drumstick products are affected by this recall.

The company received positive test results for Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made. There have been no positive test results for LM present in the Drumstick cones themselves. The products impacted by the voluntary recall were put into distribution inadvertently. No illnesses have been reported to date; the company is initiating this recall as a precautionary action to avoid any potential for consumer illness.

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The Nestlé recall is limited to the Drumstick Club 16 Count Variety Pack and 24 count Vanilla Pack, made at the company’s Bakersfield, Calif. ice cream production facility. The product identification codes can be found on the back of the packages and on the individually marked vanilla cones from the 24 count pack.  The two packs being recalled carry distinct UPC codes, as well as a “best before” date and production code.

Description	Production Code	UPC	Best Before Date
DSTK Club CP 16x4.6floz US	6244580212	72554-11096	Between June 2 - June 15, 2017
	6245580212
	6246580212
	6247580212
	6248580212
	6249580212
	6250580212
	6251580212
	6252580212
	6253580212
	6254580212
	6255580212
	6256580212
	6257580212
DSTK Vanilla 24x4.6floz US	6258580212	72554-00160	Between June 16 - June 19, 2017
	6259580212
	6260580212
	6261580212

Samsung's Galaxy Note 7 Recall

The Korean electronics giant announced Tuesday that it will halt production of its Galaxy Note 7 smartphone just weeks after U.S. regulators issued a recall of 1 million of the model for risk of catching fire. According to reports, the replacement models were also defective. Samsung's market cap shed about $18 billion following the news. Every Note 7 that Samsung receives back will be scrapped.


Brutal. 

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

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/  

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

.

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/

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.

Firm	Product	State	Purchase Website	Product Size CBD Label Claim	Lab Results (mg/g)			Lab Results %(w/w)
					CBD	Δ9-THC	Other Cannabinoids	CBD	Δ9-THC	Other Cannabinoids
Cali Stores	CBDy CBD Supplement Tincture	CA	calistores.com	1oz 200mg CBD	--	0.029	THCA: 0.16	--	0.0029%	THCA: 0.016%
Cali Stores	Hermosa Farm CannaHoney w/ CBD - 6oz	CA	calistores.com	6oz N/A CBD	--	--	THCA: <0 .01="" td="">	--	--	THCA: <0 .001="" td="">
Dose of Nature	Nano CBD Shooter *	UT	healthydoseofnature.com	32 fl oz 1088mg CBD	0.22	<0 .01="" td="">	--	0.022%	0.001%	--
Dose of Nature	Red Strap Hemp Extract 250 – Coconut Oil *	UT	healthydoseofnature.com	1fl oz N/A CBD	5.6	0.033	CBDA: 0.23 CBN: 0.106	0.56%	0.033%	CBDA: 0.023% CBN: 0.0106%
Green Garden Gold	CBD - Regular CBD-Oil	TX	greengardengold.com	15ml 100mg CBD	0.79	0.02	CBDA: <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 Gold	CBD - Strawberry Jam CBD-Oil	TX	greengardengold.com	6oz N/A CBD	0.96	0.03	CBDA: <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 Oil	Herbal Renewals CBD Hemp Oil Supplement	TX	healthyhempoil.com	1oz 100mg CBD	2.4	0.081	CBN: <0 .01="" td="">	0.24%	0.0081%	CBN: <0 .001="" td="">
Healthy Hemp Oil	Herbal Renewals 25% CBD Hemp Oil Gold Label	TX	healthyhempoil.com	3g 750mg CBD	257	8.4	CBN: 0.70	25.7%	0.84%	CBN: 0.07%
Healthy Hemp Oil	PLUS+CBD Oil Balm	TX	healthyhempoil.com	1.3oz N/A CBD	0.45	0.022	CBDA: 0.90 THCA: 0.029	0.045%	0.0022%	CBDA: 0.09% THCA: 0.0029%
Healthy Hemp Oil	Hempotion Cannabidiol CBD Concentrate	TX	healthyhempoil.com	.5oz 100mg CBD	6.6	0.21	CBN: 0.017	0.66%	0.021%	CBN: 0.0017%
Healthy Hemp Oil	Entourage Occam's Razor	TX	healthyhempoil.com	10ml 100mg CBD	6.8	--	--	0.68%	--	--
Michigan Herbal Remedies, LLC	Bluebird Botanicals Bulletproof CBD Blend	MI	michiganherbalremedies.com	1 fl oz 250mg CBD	8.7	0.35	CBDA: 0.06 CBD: <0 .1="" td="">	0.87%	0.035%	CBDA: 0.006% CBD: <0 .01="" td="">
Michigan Herbal Remedies, LLC	US Hemp Wholesale 25% CBD Hemp Oil Supplement Gold Label	MI	michiganherbalremedies.com	3g 750mg CBD	244	8.6	CBDA: 0.24 CBN: 0.8	24.4%	0.86%	CBDA: 0.024% CBN: 0.08%
Michigan Herbal Remedies, LLC	Endoca Hemp Oil	MI	michiganherbalremedies.com	10ml 15% CBD (1500mg)	159	5.5	CBDA: 10.2 THCA: 0.43 CBN: 0.47	15.90%	0.55%	CBDA: 1.02% THCA: 0.043% CBN: 0.047%
Michigan Herbal Remedies, LLC	Alternate Vape LUV-A-BULL	MI	michiganherbalremedies.com	10ml 100mg CBD	7.3	0.103	CBDA: <0 .01="" br="" style="box-sizing: border-box;">CBN: 0.011	0.73%	0.0103%	CBDA: <0 .001="" br="" style="box-sizing: border-box;">CBN: 0.0011%
Michigan Herbal Remedies, LLC	Tasty Hemp Oil - Tasty Drops Hemp Oil Supplement	MI	tastyhempoil.com	1 fl oz 250mg CBD	7.9	0.3	CBN: 0.024	0.79%	0.03%	CBN: 0.0024%
Michigan Herbal Remedies, LLC	Tasty Vape Hemp Oil - Just Peachy	MI	michiganherbalremedies.com	10ml 100mg CBD	9.6	0.136	CBDA: 0.015 CBN: 0.02	0.96%	0.0136%	CBDA: 0.0015% CBN: 0.002%
Michigan Herbal Remedies, LLC	PLUS+CBD Oil Spray	MI	michiganherbalremedies.com	2 fl oz N/A CBD	6.7	0.3	CBN: 0.024	0.67%	0.03%	CBN: 0.0024%
Morgue Juice	Morgue Juice	OK TX	morguejuice.com	150mg CBD	0.23	<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, LLC	iHempCBD Filtered CBD Hemp Oil	UT	paindmso.com	3g 35.51% - 25mg CBD/serving	350	1.6	CBN: 8.2	35.0%	0.16%	CBN: 0.82%
PainBomb, LLC	PainBomb + CBD	UT	paindmso.com	2oz N/A CBD	0.33	0.016	--	0.033%	0.0016%	--
Sana Te Premium Oils	CBD Oil - 25.2% CBD	CA	etsy.com	25mg/capsule CBD	0.031	17	THCA: 0.08 CBN: 1.1	0.0031%	1.7%	THCA: 0.008% CBN: 0.11%
				25mg/capsule CBD	0.061	19	THCA: 0.09 CBN: 1.2	0.0061%	1.9%	THCA: 0.009% CBN: 0.12%
				25mg/capsule CBD	0.017	13	THCA: 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)

2015 Warning Letters and Test Results

Page Last Updated: 02/09/2016