Tag Archives: Food & Drug Administration

U.S. Food & Drug Administration (FDA)


 
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04/29/2013 04:13 PM EDT
WESTON, FL, April 26, 2013 /CNW/ – Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
 
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04/29/2013 03:46 PM EDT
Smart & Final of Los Angeles, Calif. is recalling 2.5 lb. La Romanella Tri-Color Cheese Tortellini because it may contain undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and /or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
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04/29/2013 02:26 PM EDT
Maple View Farm is voluntarily recalling pint containers of Cookies & Cream, Carolina Crunch and Cookie Dough ice cream because the products contain allergens that were not declared on package labels. Some or all of the products contain wheat,soy, almonds and peanuts, which can cause serious allergic reactions in people who have an allergy or sensitivity to these ingredients.
 
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04/27/2013 03:07 PM EDT
Today, ConAgra Foods, Inc., (NYSE: CAG) in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Orville Redenbacher’s Classic Kettle Korn flavor ready-to-eat popcorn that may contain an undeclared allergen, milk. Certain bags of the Kettle Korn flavored ready-to-eat popcorn may have inadvertently been filled with white cheddar flavored popcorn, which contains an allergen, milk.
 
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04/26/2013 08:22 AM EDT
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.

U.S. Food & Drug Administration (FDA)


Fda
Fda (Photo credit: Wikipedia)
 

04/26/2013 11:22 AM EDT
April 23, 2013 – Saratoga Therapeutics, LLC of North Wales, PA is recalling 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components –milk protein(s) and lactose. The following lot numbers may be affected: # 0912164 expiration date 12/12 # 1110354 expiration date 10/14 People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction and people who have lactose intolerance run the risk of gastrointestinal symptoms if they consume ebA Multivitamin Supplement.
 
04/26/2013 08:22 AM EDT
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.
 
 
 
04/25/2013 11:00 AM EDT
Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent.
 
 

7th Heaven Bakeries Issues Allergy Alert on Undeclared Egg, Soy And Milk in Oatmeal Raisin Cookies

04/24/2013 12:52 PM EDT
7th Heaven Bakeries, Oklahoma City, is recalling OATMEAL RAISIN COOKIES, because they may contain undeclared dry eggs, soy lecithin, and whey solids. People who have an allergy or severe sensitivity to eggs, soy and milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
 
 
 
 

U.S. Food & Drug Administration (FDA)


English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
04/23/2013 10:44 AM EDT
Nora Apothecary & Alternative Therapies today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013.
 
04/23/2013 10:47 AM EDT
On January 8, 2013, GE Healthcare initiated a nationwide voluntary field corrective action of the Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed, which were manufactured from August 1, 2012 through December 20, 2012. Giraffe Incubators without a Servo Control Oxygen System are not impacted.

Natura Pet Expands Voluntary Recall of Dry Pet Foods Due to Possible Health Risk.

Natura Pet Products is voluntarily expanding its March 29, 2013 recall of dry pet foods because they have the potential to be contaminated with Salmonella

04/22/2013 04:04 PM EDT
April 22, 2013 – Go Max Go Foods LLC, announces that it has taken the precautionary measure of voluntarily withdrawing a limited quantity of vegan candy bar products. These products contain the following statement on the front label: “dairy-free”, which may lead to confusion for people who have allergies to milk products
 
 

U.S. Food & Drug Administration (FDA)


04/17/2013 10:44 PM EDT
Prime Food USA, 50st & 1st Ave Building # 57, Brooklyn NY 11232, is recalling Latis Brand Herring Fillet “Matiej”, Salmon Fillet Slices and Herring Fillet “Forelka” in Oil due to contamination with listeria monocytogenes.
 
 
04/17/2013 12:34 PM EDT
Abbott today announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States. The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.
 
 
04/16/2013 09:52 PM EDT
Wegmans Food Markets is recalling approximately 1,100 affected units of Wegmans Food You Feel Good About Roasted Red Pepper Dip, 8 oz. tub, with a best-by date of 5/17/13, because some of the tubs may have an incorrect ingredient label that does not list milk and eggs. People who have an allergy or severe sensitivity to milk or eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
 
 
04/16/2013 02:51 PM EDT
April 15, 2013 – Cedarlane Natural Foods, Inc., is voluntarily recalling one specific lot of O Organics Black Bean Enchiladas because they contain undeclared milk. People with an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume this product
 
 
04/15/2013 12:51 PM EDT
Winn-Dixie today announced an immediate voluntary recall of 64 FL OZ Winn-Dixie Organic 100% Apple Juice. The product is being recalled as a precaution because it could have levels of “patulin” that exceeds FDA limits.

U.S. Food & Drug Administration (FDA)


04/12/2013 01:34 PM EDT
April 12, 2013 – Wild Blue Yonder Foods of Lynn, MA is voluntarily recalling 834 cases of Chappaqua Crunch GF (Gluten Free) Simply Granola with Flax & Fruit because they contain undeclared almonds. People who have an allergy or severe sensitivity to almonds and other tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
04/10/2013 09:41 PM EDT
Henderson, NV, Green Valley Drugs is voluntarily recalling All Lots of All Sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled products is attached to this press release and can be accessed at greenvalleymed.com.
04/10/2013 08:08 PM EDT
Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED).
04/10/2013 04:41 PM EDT
Stryker Corporation (NYSE:SYK)announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting.