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.