Consumer Lawyers

Archive for May, 2012|Monthly archive page

FDA Recalls All Lab’s Sterile Eye Products

In Product Recalls on May 28, 2012 at 2:32 am

The FDA has announced a recall of all sterile ophthalmologic preparations shipped from Franck’s Compounding Lab since November 2011 because of the possibility of a fungal eye infection following use.

The recall, originally initiated on March 19, 2012, first applied only to Brilliant Blue G, an ophthalmologic dye manufactured by the lab for use during surgical procedures.

Since that time, the recall has been expanded to include all preparations labeled sterile from the company following 33 cases of fungal eye infection in seven states after administration of Brilliant Blue G or products that contain triamcinolone from the compounding lab.

Hospira recalls opioid drug cartridges

In Product Recalls on May 17, 2012 at 1:07 am

Hospira has recalled one lot of pre-filled cartridges containing the pain drug hydromorphone because the glass cartridges could contain too much medicine.

The company, which has been pressured by some product-quality issues, said there have been two reported complaints of a single “Carpuject” cartridge containing more than the amount of drug on the product’s label.

There have been no reports of adverse events related to this issue for this product lot, Hospira said, but overdoses on opioid pain drugs such as hydromorphone can pose life-threatening consequences.

Whole Foods Recalls Carrot Cake Cupcakes

In Food Recalls on May 17, 2012 at 1:05 am

Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.


FDA Recalls Korean Fish

In Food Recalls on May 17, 2012 at 1:03 am

According to information released by the Food and Drug Administration (FDA) all Korean certified shippers have been removed from the Interstate Certified Shellfish Shippers List (ICSSL) effective May 1, 2012.

All fresh and fresh frozen molluscan shellfish from Korea should be considered from an unapproved source.  In addition, FDA considers all fresh and fresh frozen molluscan shellfish and all products subsequently derived from fresh and fresh frozen molluscan shellfish from the Republic of Korea to be adulterated. Therefore, it may be prudent to not further distribute product pending forthcoming details on what we might reasonably expect could be a fairly extensive recall of the product. FDA is working to establish a strategy for final disposition of the implicated product. Detailed information will be provided as soon as it is available. Please note that this message does not preclude States from taking action as appropriate.


May 1, 2012 DMAA News: FDA challenges marketing of DMAA products for lack of safety evidence

In Uncategorized on May 1, 2012 at 10:31 pm

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a “natural” stimulant.
The companies receiving warning letters and their product names are:
 Company  Product(s)
 Exclusive Supplements Biorhythm SSIN Juice
 Fahrenheit Nutrition Lean Efx
 Gaspari Nutrition Spirodex
 iSatori Global Technologies, LLC PWR
 Muscle Warfare, Inc. Napalm
 MuscleMeds Performance Technologies Code Red
 Nutrex Research Hemo Rage Black
Lipo-6 Black Ultra Concentrate
Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate
Lipo-6 Black Hers
 SEI Pharmaceuticals MethylHex 4,2
 SNI LLC Nitric Blast
 USP Labs, LLC Oxy Elite Pro
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.

Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.
The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.
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