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Wednesday, March 20, 2013

Avastin Eye Medicine Recalled

Avastin Unit Dose Syringes by Clinical Specialties

Recalled: Potential For Serious Eye Infection

Avastin Eye Injection

AUDIENCE: Eye Care Health Professionals, Patients


Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.


This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see Press Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physician’s office setting and syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.


Doctors that have product which is being recalled should stop using the Avastin immediately. Consumers with questions regarding this recall may contact Clinical Specialties by phone at 866-880-1915 or e-mail address at Monday through Friday between the hours of 10 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Tuesday, March 12, 2013

Warning: Antibiotic Azithromycin May Cause Fatal Heart Rhythms

Azithromycin (Zithromax or Zmax): Risk of Potentially Fatal Heart Rhythms

AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional

ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.

FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.

BACKGROUND: Azithromycin is marketed under the brand names Zithromax and Zmax. Change to “FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease

RECOMMENDATION: Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.  FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:
  • Download form 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
Read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication, at:

Night Bullet, Male Sexual Performance Supplement Recalled

Green Planet, Inc. Issues a Voluntary Nationwide Recall 

of One Lot of "Night Bullet" 

Marketed as a Supplement to Support Male Sexual Performance

Contains Undeclared, Potentially Hazardous Active Ingredient

March 11, 2013 - Green Planet, Inc. is conducting a voluntary consumer recall of a product sold as a dietary supplement under the brand name of "Night Bullet," found to contain trace amounts of an analogue of an FDA-approved drug.
Finished product of Night Bullet was tested and found to contain trace amounts of an analogue of an FDA-approved drug. Analytical tests conducted by the Food and Drug Administration (FDA) of Night Bullet found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil. Sulfohydroxyhomosildenafil and Aminotadalafil are an analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED) making this product an unapproved drug.
These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions and they may seek products to enhance sexual performance. Additionally sildenafil may cause side effects such as, headaches and flushing. Green Planet has not received any reports of adverse events related to this recall.
Night Bullet is marketed as a supplement for male enhancement. The recalled products are in capsule form, packaged in one (1) count blister packs. The lot and expiration date can be found on the back of the package. The following lot is being recalled:
Product:  Night Bullet
Batch Lot #:  B43N032
UPC Code:  018505122233
Expiration Date:  10/20/15

Night Bullet was sold nationwide between October 2012 and March 2013 to wholesalers and sample provided at trade shows.
Green Planet is notifying its wholesalers through written correspondence. We urge consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return the product to their place of purchase. Consumers may also return products directly to Freedom Trading. Customers can call the Company at 877-621-2048 Monday through Friday from 9:00 am – 5:00 pm PST for instructions on the return and refund process.
Any adverse events 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:
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Monday, March 11, 2013

Premium Cat Food Recalled: Low Levels of Vitamin B1

Premium Edge, Diamond Naturals and 4health Dry Cat Food Formulas Voluntarily Recalled Due to Possibility of Low Levels of Thiamine (Vitamin B1)

March 10, 2013 - COLUMBIA, S.C. - Diamond Pet Foods is voluntarily recalling limited production codes of Premium Edge Finicky Adult Cat Formula dry cat food, Premium Edge Senior Cat Hairball Management Formula dry cat food, Premium Edge Kitten Formula dry cat food, Diamond Naturals Kitten Formula dry cat food and 4health All Life Stages Cat Formula dry cat food. Tests conducted by the company indicated the products might have a low level of thiamine (Vitamin B1). There have been no complaints regarding thiamine levels, or any other health issues, related to these products. In association with this voluntary recall, Diamond Pet Foods has tested all other Diamond brands for thiamine deficiency to ensure the safety of the cat food it manufactures. No other product manufactured by Diamond Pet Foods is involved in this voluntary recall.
Only product with the following Best By dates and Production Codes are included in the voluntary recall. Further distribution of these affected production codes has occurred through online sales. It is best to check the production code to determine if the product has been recalled or not.
Production Codes
Best By
Premium Edge Finicky Adult Cat Formula
18 lb. bags
Premium Edge Finicky Adult Cat Formula
6 lb. bags
Premium Edge Senior Cat Hairball Management Formula
6 lb. and
18 lb. bags
Premium Edge Senior Cat Hairball Management Formula
6 lb. and
18 lb. bags
Premium Edge Kitten Formula
6 oz. samples,
6 lb. and 18 lb. bags
Diamond Naturals Kitten Formula
6 oz. samples and 6 lb. bags
4health All Life Stages Cat Formula
5 lb. and
18 lb. bags

"At Diamond Pet Foods, we have a process where we continuously test our products, and this process allowed us to find the undesired levels of thiamine in some of our cat formulas. Our food safety protocols are designed to provide safe food on a daily basis," says Michele Evans, Ph.D., Diamond Pet Foods Executive Director of Food Safety and Quality Assurance. "In the event an error occurs, we have the data to quickly alert pet owners, giving them the confidence they demand of a pet food manufacturer."
Pet owners who are unsure if the product they purchased is included in the recall, or who would like replacement product or a refund, may contact the Pet Food Information Center at 1­888­965­6131, Sunday through Saturday, 8 a.m. – 6 p.m. EST. Consumers also may visit Website - for additional information.
Cats fed product with the previously listed Production Codes and Best By dates exclusively for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats in maintaining normal nervous system function. Symptoms of thiamine deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting and weight loss. In advanced cases, neurological signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, falling, circling and seizures. Pet owners should contact their veterinarians immediately if a cat is displaying any of these signs. If treated promptly, thiamine deficiency typically is reversible.




Dog and Cat Foods Might Pose Danger to Your Health

How to Protect Your Family From Food-borne Illness in Your Pet's Foods

Recently, I've noticed that more and more recalls have been issued for pet foods due to contamination with dangerous bacteria such as salmonella and e. coli.  Not only do these foods pose a danger to your beloved pets, but they also are a hazard to you and your family!  While salmonella in pet foods and treats can cause serious infections in your dog or cat, they can cause very real problems in people too--especially children, the elderly, and people with compromised immune systems. 
new pet advice
Salmonella in pet foods and treats potentially can be transferred to people ingesting or handling the contaminated products.Toddlers are notorious for messing around with pets' dishes and (as unsavory as it sounds) they sometimes will even eat the dog or cat's food.  But even if you keep pet food well away from your little ones, you might still be at risk of contracting a serious infection due hidden bacteria in your animals' foods.  Luckily, there are steps you can take  to help prevent these food-borne illnesses that arise from pet food contamination..  Following the guidelines listed below will go a long way toward protecting your family and your fur-babies as well.

When Buying Pet Food

  • Purchase products that appear to be in good condition, without signs of damage to the packaging such as dents or tears.

When Preparing Pet Food

  • Thoroughly wash your hands for 30 seconds with hot soapy water after handling pet foods and treats.
  • Wash pet food bowls, dishes, and scooping utensils with soap and hot water after each use.
  • Do not use your hands or the pet's feeding bowl as a scooping utensil—use a clean, dedicated scoop or spoon.
  • Dispose of old or spoiled pet food products in a safe manner, such as in a securely tied plastic bag in a covered trash receptacle.

Safely Storing Pet Food

  • Securely cover and refrigerate promptly or discard any unused, leftover wet pet food.
  • Refrigerators should be set at or below 40º F.
  • Dry products should be stored in a cool, dry place—under 80º F.
  • If possible, store dry pet food in its original bag inside a clean, dedicated plastic container with a lid, keeping the top of the bag folded closed.
  • Keep pets away from food storage and preparation areas.
  • Keep pets away from garbage and household trash.

Stay Alert

  • Finally, stay alert to breaking news on product recalls by subscribing to Totally Recalled!  where you will always find  timely updates to help you avoid exposure to any known problems as they occur--such as this pet treat recall issued today!  

"Diggin' Your Dog" Dog Treats Recalled Due to Salmonella

Diggin' Your Dog Recalls Strippin' Chicks Pet Treats Distributed in Colorado and Nevada Due to Possible Salmonella Hazard

March 7, 2013 - Diggin' Your Dog™ announced today that they are voluntarily withdrawing one lot of its Strippin' Chicks™ Pet Treats produced on 8-30-12 because they have the potential to be contaminated with Salmonella. The sample was obtained in Colorado and the company has accounted for its distribution in Colorado of this lot.
No other Diggin' Your Dog™ products, lots, or production dates are affected.
The lot being voluntarily withdrawn is: Strippin' Chicks™ Pet Treats 5 oz Bag. Lot Code 250322 Use By Date: 2-23-14.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Animals with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some animals will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy animals can be carriers and infect other animals or humans. If your animals have consumed the recalled product and have these symptoms, please contact your veterinarian.
Diggin' Your Dog™ takes the matter of consumer protection and safety very seriously and strives to deliver only the safest products available.
Diggin' Your Dog™ is committed to providing the highest-quality pet treats possible to their customers. As a precautionary measure, Diggin' Your Dog™ will continue to produce all products in very small, handmade lot batches.
No Other Diggin' Your Dog™ products are affected by this voluntary withdrawal. Customers who have purchased this lot code are urged to stop feeding the product to their pet, remove the lot code from the packaging, and discard the contents.
A full refund, plus $1.00 to cover postage will be received by mailing the UPC and lot code to:
Diggin Your Dog, LLC, PO Box 17306 Reno, NV 89511.
All refunds will be processed within ten business days (plus postage time).
Diggin' Your Dog™ values the efforts of all agencies dedicated to the safety of the industry and is committed to consumer safety at all levels.
For questions or more information, contact Diggin' Your Dog™.
By phone at 775-742-7295 Mon-Fri 8:30AM - 4:00PM Pacific Standard Time
Email us at

Thursday, March 7, 2013

Chicken of the Sea Tuna Recalled, Poorly Sealed Cans

Tri-Union Seafood Issues Voluntary Recall on Select 5-Ounce Chunk White Albacore Tuna in Water

FOR IMMEDIATE RELEASE - Mar. 6, 2013 – Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water.
The seams on the lids of the cans do not meet the standard for seam quality. Cans that do not meet seam standards could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed. There have been no reported illnesses to date, and Tri-Union Seafoods is issuing this voluntary recall to ensure the highest margin of safety and quality.
The specific product being recalled is Chicken of the Sea Brand 5-ounce chunk white albacore tuna in water sold at retail nationwide in single cans between February 4, 2013 and February 27, 2013.
The UPC code (also known as the bar code) is found on the label of the product and is 0 48000 03355 0. The Best By date is printed on the bottom of the can and is 01/18/17. The product lot codes that are part of this voluntary recall can also be found on the bottom of the can and include:
"The health and safety of our consumers is paramount. As soon as we discovered the issue, we took immediate steps to issue this voluntary recall by alerting our customers who received the product and by asking them to remove it from store shelves," said Shue Wing Chan, President of Tri-Union Seafoods.
No other codes of this product or other Chicken of the Sea products are affected by this voluntary recall.
Consumers looking for additional information can call our 24 hour Recall Information line at 1-800-597-5898.



Rebecca Howe Schmidt
Teresa Siles
Nuffer, Smith, Tucker

Wednesday, March 6, 2013

Cargill Cattle Feed Recalled: Deficient in Vitamins A, D & E!

Cargill’s animal nutrition business conducts voluntary recall of select mineral product used in ruminant feed

FOR IMMEDIATE RELEASE - March 5, 2013 - Cargill’s animal nutrition business today announced a voluntary recall of certain brands of its ruminant mineral products because they were deficient in vitamins A, D and E. The affected products were manufactured at Cargill’s facilities in McPherson, Kansas, and Montgomery City, Missouri, between Dec. 7, 2012, and Feb. 27, 2013. The absence of added vitamins in these products was due to an oversight in Cargill’s manufacturing process that has been remedied.
No adverse health effects related to these products have been reported to date.
This recall is limited to only those products and lot code ranges listed below. The affected product was sold in 50 pounds bags and the lot code can be found printed on the product tag that is attached to the bag. No other Cargill Animal Nutrition products are affected by this recall. Affected products are:
Product Code Beginning with
Product Name
Lot Code Range
Cattle Grazers All Purpose Mineral
522349 to 523058
Right Now Emerald
523024 to 523058
613030 to 613058
Right Now Onyx
522342 to 523058
612356 to 613058
Nutrena® NutreBeef Stocker Summer Mineral
522342 to 523058
Nutrena® NutreBeef Stocker Wheat Mineral
522342 to 523058
Nutrena® NutreBeef Breeding Herd Mineral
522342 to 523058
Nutrena ® NutreBeef Cattle - Winter Mineral
522349 to 523058
Customers should return remaining products to their local distributor for a full refund. For more information, including complete product codes, sub-codes, and photos of products involved, go to or call toll free 1-866-420-5425, 8 a.m. to 4:30 p.m. CT, M-F.



Lynda Michielutti

Monday, March 4, 2013

Ezekiel 4:9 Cereal Recalled Due to Tree Nut Allergen

Food For Life issues Recall - Allergy Alert - Undeclared Allergen in Food For Life Ezekiel 4:9 Cereal

FOR IMMEDIATE RELEASE - March 1, 2013 - Food For Life Baking Company of Corona, California is recalling 15,369 cases of Ezekiel 4:9 Sprouted Grain Cereal shipped between November 20, 2012 to February 11, 2013, because the product may be mislabeled and may contain an undeclared allergen - almond:
Ezekiel 4:9 Cereal - Original
M3232, M3313, M3512, M3565
Ezekiel 4:9 Cereal - Golden Flax
M3253, M3309, M3414, M3439,
 M3523, N0068, N0165
Ezekiel 4:9 Cereal - Cinnamon Raisin
M3232, M3313, M3328, M3425,
M3512, M3527, M3537, N0045,
Individuals sensitive to almond protein can suffer a moderate to acute life-threatening allergic reaction, if consumed.
This recall has been initiated as a precautionary measure following a random allergen test performed at the facility concluding that the product may contain an undeclared allergen.
The recalled products were sold nationwide through health food distributors and natural food retailers. Food For Life Ezekiel 4:9 Sprouted Grain Cereals are sold dry in 16 oz. (454g) Cereal Cartons and bear the following descriptions:
Food For Life, Ezekiel 4:9 Boxed Cereal –Original, (Orange Carton)
Food For Life, Ezekiel 4:9 Boxed Cereal –Golden Flax, (Blue Carton)
Food For Life, Ezekiel 4:9 Boxed Cereal –Cinnamon Raisin, (Purple Carton)
This recall is being made with the knowledge and in cooperation with the Food and Drug Administration.
No illnesses have been reported to date in connection with this issue.
Consumers who have purchased any of these products are urged to return them unopened to the place of purchase for a refund.
Consumers with questions may contact us toll free at: (800) 797-5090.  


Gary Torres, Communications Director 
(951) 279-5090

See's Candies Recalled Due to Peanut Allergen

See’s Candies, Inc. Issues Allergy Alert on 1.7oz Divinity Egg with Walnuts, code L.A.D. 102/13

FOR IMMEDIATE RELEASE -February 28 , 2013 - See’s Candies, Inc. of San Francisco, Calif., is recalling one code of 1.7 ounce Divinity Easter Egg with Walnuts, because some boxes labeled Divinity with Walnuts may actually contain Peanut Butter Eggs. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. The total number of boxes produced that may contain peanut butter is 64 of a run of 2,048 Divinity with Walnuts Eggs.
The product was distributed to See’s shops in Arizona, California, Nevada, Missouri, New Mexico, Oklahoma, Texas and Utah.
The product is sold individually in boxes labeled See’s Candies Divinity With Walnuts, 1.7 oz. The only code affected by this recall is L.A.D. 102/13, and is visible on the inside back of the box, through the cellophane window.
There is no reported allergen reaction or illness attributed to this product.
Concerned consumers should return the product or the receipt to any See’s Candies Shop or the location where it was purchased for a full refund or exchange. Any consumers with questions about this recall should also contact See’s Consumer Affairs at 1-800-789-7337.


Susan Pasarow / Christina Wong / Lydia You / Rosa Muniz
Murphy O’Brien Public Relations

Friday, March 1, 2013

Easter Candy Recalled Due to E-Coli!

Zachary Confections, Inc. Announces Recall of Chocolate Covered Marshmallow Eggs 

February 27, 2013 - Zachary Confections, Inc., today announced a voluntary recall of certain production lots of its Zachary Chocolate Covered Marshmallow Eggs because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Zachary Confections has initiated this voluntary recall in response to a test result indicating the potential for Salmonella contamination in a sample taken during routine post-production testing from one of the production lots of product that is the subject of this recall. Out of an abundance of caution, Zachary Confections is recalling all lots of product that may have been affected.
The product is packaged in white egg crates with purple, green and yellow lettering. The specific Case UPC numbers, Unit UPC numbers, Code Dates and Best Buy Date for the recalled products are listed below.

Case UPC
Unit UPC
Best By
Zachary Chocolate Covered Marshmallow Egg Crates 5 oz 
[Product # 31-797]
(white colored egg crate with colored lettering)
1 00 75186 31797 3
0 75186 15797

D3145E; F3145E; D3245E0

 The Best Buy Date and Code Dates are located on the side panel of the product packaging next to the Unit UPC bar code label.
The recalled product was manufactured on February 20 and February 21, 2013, and was shipped from the Zachary Confections’ facility on February 21 and February 22, 2013.The recalled products have been distributed to some retail stores located in sections of Iowa, Minnesota, North Dakota, South Dakota and Wisconsin.
No other Zachary Confections products are involved in this recall.
To date Zachary Confections has not received any consumer illness complaints associated with its products. As part of its priority to ensure the safety and quality of all of its products, Zachary Confections is issuing the voluntary recall.
Production of the product has been suspended while FDA and the company continue their investigation as to the source of the potential problem.
"We are dedicated to manufacturing wholesome products for our customers," said George Anichini, Vice President – Operations of Zachary Confections. "Consistent with that dedication, we are taking this voluntary action."
Consumers who have purchased the recalled products should destroy or return them to the store where they were purchased. Anyone requiring more information should contact Zachary Confections Customer Service at (765) 654-8356 between the hours of 8:00am and 4:30pm EST.

For more information contact:


George Anichini