melting mama

Liquid Supplements Recalled By Protica Inc.

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Liquid Supplements Recalled By Protica Inc.

Contact:
James Duffy
jduffy@protica.com

FOR IMMEDIATE RELEASE – July 06, 2009 - On July 5, 2009, FDA alerted consumers that Protica Inc. of Whitehall, PA, had undertaken a voluntary recall of its liquid protein dietary supplements and high energy products marketed under the IDS Sports’ New Whey™ and iSatori’s Hardcore Energize Bullet™ brands, respectively. This recall is limited to specific lots of the two branded products.

The FDA notice of July 5 warned consumers not to buy or use New Whey™ Fruit Punch lot 1960; New Whey™ Blue Raspberry lot 1944; Hardcore Energize Bullet Blue Rage lots 1961, 1962, and 1794; and Hardcore Energize Bullet Black Rush lot 1963.  Several lots of potentially affected product distributed in the United States were inadvertently not included in the FDA notice. The additional lots are:

Lot Code	Product Identification
1750	New Whey, Orange 42g (12 pack)
1887	New Whey, Orange 42g (12 pack)
1924	New Whey, Orange 42g (12 pack)
1928	New Whey, Orange 42g (12 pack)
1934	New Whey, Orange 42g (12 pack)
1946	New Whey, Orange 42g (12 pack)
1920	New Whey, Blue Raspberry 42g (12 pack)
1930	New Whey, Blue Raspberry 42g (12 pack)
1936	New Whey, Blue Raspberry 42g (12 pack)
1925	New Whey, Grape 42g (12 pack)
1949	New Whey, Grape 42g (12 pack)
1972	New Whey, Fruit Punch 42g (12 pack)
1973	New Whey, Fruit Punch 42g (12 pack)
1932	New Whey, Fruit Punch 25g (12 pack)
1900	New Whey, Blue Raspberry 25g (12 pack)
1959	New Whey, Blue Raspberry 25g (12 pack)
1945	Energize Bullet; Blue Rage flavor (12 pack)

“Our primary concern is ensuring our customers’ health and safety,” said James Duffy, founder and president of Protica. “Fortunately, no reports of injury have been received. We have been working with the FDA and its OCI (Office of Criminal Investigations) and are cooperating fully with investigations initiated by the FDA and Health Canada.”

All potentially affected lots of New Whey™ and Hardcore Energize Bullet™ were shipped in January 2009. The caps of tampered products are devoid of any print – the ‘best by’ date and lot code that appear on the cap of every container do not appear on caps from the tampered products.

Consumers who have purchased any of the above products can return them to the place of purchase or to Protica for a full refund. Consumers with any questions should contact Protica at 1-800-PROTICA (1-800-776-8422) between 8a and 5p, Monday through Friday.

Any adverse reactions experienced with the use of these products should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Protica, founded in 2001, is headquartered in Whitehall, PA. The company relocated from Horsham, PA, to the Lehigh Valley in January 2009, occupying and rehabilitating the former vacant Lehigh Valley Dairy Plant near Allentown. Protica has approximately 60 employees and is privately held.

Remember what I juuuuuust said, huh? Do you?

Did I JUST say that Mr's mom was "alright," aside from all the various crap I described?  DID I?

GAH.

She was "fine" yesterday, spent time out, went home to bed, wasn't feeling hot.  In the hospital this morning, with a high fever, joint pain, and a sudden serious red rash over much of her torso and body.  Diagnoses via cell phone as of a little while ago:  Severe Cellulitis.  No, SEVERE.  I am trying to get the photo from my phone to translate to the blog.

She's had it before -- never to this extent -- so suddenly and nasty.

Do you still want plastic surgery?!  I am only assuming it's a directly correlation to the plastics she had one month ago, and still had open holes.

Please note, the most recent surgery was a revision of a revision (of a revision?) of an original failed breast reconstruction after massive weight loss.  The original surgery was a ICAP breast procedure. The skin from the back is used to make new breasts, no implants.  They broke, several times.)

JAYSUS.  Enough already.  This is a stern warning.

Day 4 of Bariatric Bootcamp. The day the scale cried.

Weight - 169 lbs. (Down from 171 lbs.)

I stepped on the scale, it screamed and begged for mercy, "WOMAN!  YOU HAVE GAINED!"  I know.  I was what, 152? in December.  I gained 15-21+ lbs. in seven months.  At that rate, I could TOTALLY regain everything.  THAT would be good times, can you imagine TRYING to regain, like on purpose? 

Most of it jumped on the moment I stopped taking Topamax for seizure control.  I told you that would happen.  Topamax is an anti-eating drug, too, and it works.  I'd take it in a heartbeat again if it didn't make me brain-dead AND have no feeling in my hands and lower legs!  I asked the neuro a while ago if we could add something on to take away the hungry-hungry-hippo from the Dilantin, but he wants me to make sure I see a pharmacologist to do so, and getting up to the city to do so is just getting pushed off again and again, I can't really get there.  Hence the reason I am trying to get a grip nutritionally too - writing my food down - trying to hit a calorie goal - and attempting to follow a plan.

This 28 day plan is likely to get a week tacked on to the end.  This week has really been a wash with the red tide, and while I have ended up a few pounds down, it's just water, I'm sure.

"Drop Dead Diva" Ditzy blonde dies, comes back as fat smart lady. Wha??

Meh. I'm too cranky to bitch about this, I'm just glad the stereotyping for fat brunette is a smart chick. ;)

PS. I <3 Margaret Cho, however.

Bacon tattoos.

Greasy Tattoos - Man Shares Love for Bacon with the World (GALLERY)

(TREND HUNTER) Yes, the tattoos shown above are real. The first image comes from a man known as FriendlyFire who took to his Flickr page to show off his bacon love and his ink. The tattoo apparently came about after… [More]

Gastric Banding Less Effective than Other Procedures

I share everything I find. Please do not think I share this just because I'm trying to knock your band. I could care less WHAT weight loss surgery procedure you have, as long as you're on a path to GETTING HEALTHY and STAYING that way, okay?

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ASMBS: Gastric Banding Less Effective than Other Procedures:

Patients who underwent laparoscopic adjustable gastric banding achieved less weight loss and less improvement in comorbid conditions than those who had gastric bypass or sleeve gastrectomy.

Slightly more than half of gastric banding patients lost more than 50% of excess weight after five years compared with more than 90% of patients who underwent laparoscopic Roux-en-Y gastric bypass, Diego Awruch, MD, reported at the American Society of Metabolic and Bariatric Surgery.

Surgical failure, defined as less than 50% excess weight loss, was almost six times more common with gastric banding.

"Laparoscopic adjustable gastric banding was associated with fewer complications, but the percent weight loss at one and five years was inferior to laparoscopic Roux-en-Y gastric bypass," said Dr. Awruch, of Pontificia Universidad Catolica in Santiago, Chile.

"Surgical failure occurred in more than 40% of patients who underwent gastric banding, and 16% of the patients required surgical revision of the initial procedure," he said.

Similar disparities in weight loss occurred in the comparison of gastric banding and sleeve gastrectomy.

Across the entire range of body mass index (BMI), laparoscopic sleeve gastrectomy led to greater weight loss, said David Schumacher, MD, of Wright State University in Kettering, Ohio.

Dr. Awruch reported outcomes for 91 patients treated with laparoscopic Roux-en-Y surgery and 62 who underwent gastric banding from 2001 to 2003.

Five-year follow-up was available for 73.6% of the gastric bypass patients and 91.5% of the gastric banding patients.

Comparison of baseline characteristics showed that bypass patients weighed significantly more (106.4 versus 97.6 kg, P<0.001) and had a significantly higher BMI (39 versus 35, P<0.001).

Gastric bypass was associated with a higher rate of early complications (14.2% versus 1.6%, P=0.009). In addition, nine bypass patients required reoperation or endoscopic dilatation compared with one patient in the banding group.

Late complications occurred in 37.3% of bypass patients compared with 27.4% of gastric banding patients, but the difference did not reach statistical significance. A higher proportion of gastric banding patients required reintervention (23 of 62 versus 20 of 91).

Percent weight loss at five years averaged 92.9% with gastric bypass compared with 59.1% with gastric banding (P<0.001).

Dyslipidemia, insulin resistance, hypertension, and type 2 diabetes improved or resolved in 80% to 100% of bypass patients compared with 20% to 40% of the gastric banding group.

At five years, 94% of bypass patients and 54.4% of gastric banding patients had maintained >50% excess weight loss.

Dr. Schumacher reported outcome data for 104 patients who underwent laparoscopic sleeve gastrectomy and 227 who had gastric banding from January 2006 through August 2008. Follow-up data were 99% as of January 2009.

Among patients followed for at least 18 months (about half of the total), weight loss averaged 133.82 lb in the sleeve group versus 58.93 lb in the banding group.

For the same time interval, excess weight loss averaged 55.54% with sleeve gastrectomy versus 38.65% with banding.

Stratification of patients by baseline BMI showed that sleeve patients had a greater excess weight loss in patients with BMI more than 50 (50% versus 33%), 40 to 49 (68% versus 40%), and less than 40 (90% versus 43%).

Readmission rates were 6% of sleeve gastrectomy patients and 1.3% with gastric banding. One patient (0.96%) in the sleeve group required reoperation compared with 19 (8.4%) gastric banding patients.

"Laparoscopic sleeve gastrectomy appears to allow greater weight loss in all BMI classifications over time with fewer reoperations," said Dr. Schumacher. "The most efficient weight loss occurred in the lowest BMI classification.

"Laparoscopic sleeve gastrectomy can be used effectively as a primary operation in any weight classification, achieving a greater than 50% excess weight loss in all BMI subsets."

Primary source: American Society of Metabolic and Bariatric Surgery
Source reference:
Awruch D, et al "Laparoscopic roux-en-Y gastric bypass versus laparoscopic adjustable gastric banding 5 years follow-up" Surg Obes Relat Dis 2009; 5(3S): Abstract PL-122.

Additional source: American Society of Metabolic and Bariatric Surgery
Source reference:
Schumacher DL, et al "Comparison of gastric sleeve and adjustable gastric band over an extended time frame" Surg Obes Relat Dis 2009; 5(3S): Abstract PL-215.

Bariatric Advantage Sugar-Free Omega-3 Chew

I handed a wrapped Bariatric Advantage Sugar-Free Omega-3 bite to the Mr:

"Eat this and give me your review."  I tell him.

"What is it?" he looks at me wondering if I am again poisoning him.

He realizes now that I want a spur of the moment reaction to a product, not something swayed by the fact that he knows what it is or where it came from.  Just eat it and tell me what you think -- as a neutral party.

He opens the chew, and eats it. 

"It tastes like one of those candies." Searching for the words, he chews and thinks.  "Like, a, ummm, soft taffy or a Starburst.  These are good.  I could eat these, now what is it?"

So there's your man-view.  Tastes like candy, and he can eat it.  I don't tell him what it is -- because like a little kid -- he'll be all, "WHAT?!"

" These delicious chews make taking Omega-3s as easy as can be! Each sugar-free berry flavored chew provides 160mg of EPA and DHA, to support optimal essential fatty acid intake"

	Nutrient Amount % DV Calories 20 Calories from fat 10 g Fat 1 g Cholesterol 5 mg Total Carbohydrate 4 g Vitamin C 14 mg Sodium 10 mg Total Omega-3 Fatty Acids 160 mg Per one chew Dose = 1 chew or as directed

My review is the same, except longer. I have been a fan of the GNC Fish Oil Chews since last year -- my only complaint was the high sugar level. NOW! I have a choice. The Bariatric Advantage Omega-3 Chews are SUGAR-FREE and make a lot more sense for a gastric bypasser to get in those essential fatty acids in. For someone like me, with a very limited diet, it's essential to get in the essentials. (I eat quite little variety, and zero seafood.)

Each chew is individually wrapped, and opening the bag you get a huge whiff-o-raspberry.  They smell amazing.  The texture is smooth, and soft.  As compared to the GNC Bites --- these have no waxy feel --- GNC bites have a waxy texture.  These are more like, soft pulled taffy with no stickiness.  You can feel a teensy bit of the sugar replacement in the chew, but it is very pleasant.  In fact these chews are quite crave-worthy, because they taste like candy.

Later, after you eat it, there is ZERO FISH BURP potential.  With typical fish-oil supplements, there is a chance that you will be tasting "it" for hours. EWW EWW EWW!  These, no aftertaste.

• Product - Bariatric Advantage Sugar-Free Omega-3 Chew
• Via - Bariatric Advantage
• Price - $14.99
• Pros - Sugar-free tasty way to get in your omegas without burping fish gas.
• Cons - Sugar alcohols.
• Rating - Pouchworthy, MM.