NEWS: U.S. Food and Drug Administration (FDA)

Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients

FDA: Recalls - 3 hours 45 min ago
Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers. Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.

Nest Collective Voluntarily Recalls Select Revolution Foods Jammy Sammy - Strawberry Jam & Peanut Butter Snack Size Sandwich Bars Due to a Labeling Error (Undeclared Peanut on Inner Wrapper)

FDA: Recalls - 7 hours 9 min ago
Nest Collective ™ announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy™ - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package.

California Firm Recalls Prepared Sandwiches that Contain Hard-Cooked Eggs

FDA: Recalls - Fri, 02/03/2012 - 23:48
GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes. GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems.

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up

FDA: Medical Watch - Fri, 02/03/2012 - 17:18
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.

Greencore, USA – Cincinnati, Recalls Egg Salad Sandwiches with Brand Name Quick Café and Take Away Café because of Possible Health Risk

FDA: Recalls - Fri, 02/03/2012 - 16:32
Greencore, USA is recalling approximately 550 pounds of egg salad sandwiches. The sandwiches contain eggs manufactured by Michael Foods Inc that are the subject of a previous recall due to possible contamination with Listeria Monocytogenes.

Pedinol Pharmacal Inc. Announces Health Advisory for Gris-PEG (griseofulvin ultramicrosize) 125mg and 250mg

FDA: Recalls - Fri, 02/03/2012 - 13:02
Pedinol Pharmacal Inc. today announced that it is advising healthcare professionals, pharmacists and patients of a potential problem with Gris-PEG (griseofulvin ultramicrosize) 125mg and 250mg manufactured and packaged by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

FDA: Medical Watch - Fri, 02/03/2012 - 10:06
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

Allison’s Gourmet Kitchens Recalls Prepared Salads that Contain Hard Cooked Eggs Due to Potential Health Risk.

FDA: Recalls - Thu, 02/02/2012 - 21:56
Allison’s Gourmet Kitchens was notified by their egg supplier, Michael Foods, Inc. that they are recalling numerous lots of their hard cooked eggs due to the potential for contamination by Listeria monocytogenes. Some of these eggs were introduced into our process to manufacture these effected products.

Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093

FDA: Recalls - Thu, 02/02/2012 - 17:20
Bedford Laboratories, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011

Wegmans Recalls Various Prepared Foods That Contain Hard-Cooked Eggs Produced by Michael Foods

FDA: Recalls - Thu, 02/02/2012 - 16:23
Wegmans Food Markets, Inc. is recalling hard-cooked eggs, as well as prepared foods that contain hard-cooked eggs, sold between January 23 and February 1, 2012 because the eggs have the potential to be contaminated with Listeria monocytogenes, an organism which 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. 

S&M USA Enterprise Issues an Alert on Undeclared Sulfites in Zhang Zhou Brand Tremella

FDA: Recalls - Thu, 02/02/2012 - 14:36
S&M USA ENTERPRISE is recalling ZHANG ZHOU BRAND TREMELLA because it may contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Updated News Release With Corrected Lot Numbers: Advanced Animal Nutrition Recalls Dog Power Dry Dog Food

FDA: Recalls - Thu, 02/02/2012 - 13:19
Advanced Animal Nutrition today announced a voluntary recall of its dry Dog Power Dog Food- due to aflatoxin levels that were detected above the acceptable limit. The affected products were manufactured between Jan. 4, 2011, and Nov. 18, 2011.

W & C International Import Inc. Issues An Alert On Un-Eviscerated "Rely" Dried Yellow Croaker

FDA: Recalls - Thu, 02/02/2012 - 11:44
W & International Import Inc. is recalling "Rely" Dried Yellow Croaker because the product was found to be un-eviscerated. The recalled "Rely" Dried Yellow Croaker was distributed nationwide in bulk cardboard boxes.

W & C International Import Inc. Issues an Alert on Un-eviscerated “Rely� Sardine Anchovies

FDA: Recalls - Thu, 02/02/2012 - 11:41
W & International Import Inc. is recalling “Rely� Sardine Anchovies because the product was found to be un-eviscerated. The recalled “Rely� Sardine Anchovies were distributed nationwide in 7.0 oz. plastic packages. The “Rely� Sardine Anchovies are a product of China.

Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016

The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..

Michael Foods Recalls Hard-Cooked Eggs Packed In Brine Sold In 10- And 25-Pound Pails Because Of Possible Health Risk

FDA: Recalls - Wed, 02/01/2012 - 16:16
Michael Foods, Inc. is recalling specific lot dates of hard-cooked eggs in brine sold in 10- and 25-pound pails for institutional use that were produced at its Wakefield, Nebraska facility because the product has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA and industry reach agreement in principle on medical device user fees

FDA: Press Releases - Wed, 02/01/2012 - 09:48
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets

FDA: Medical Watch - Wed, 02/01/2012 - 08:25
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

President Global Corporation Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg

FDA: Recalls - Tue, 01/31/2012 - 22:43
President Global Corp., Buena Park, CA is recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens.

Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets

FDA: Recalls - Tue, 01/31/2012 - 21:52
Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market.
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