Salmonella outbreak due to RAW MealOrganic Shake and Meal Replacement products

What is the problem and what is being done about it?
The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC), and state and local officials are investigating a multi-state outbreak of Salmonella Virchow. The epidemiological and laboratory evidence available at this time suggests that RAW Meal Organic Shake and Meal Replacement products manufactured by Garden of Life LLC of Palm Beach Gardens, Florida are a likely source of this outbreak.

Five sick, three die after eating ice cream products from Blue Bell Creameries

For the first time in 108 years, Blue Bell announces a product recall.

"One of our machines produced a limited amount of frozen snacks with a potential listeria problem," Blue Bell announced in a press release. "When this was detected all products produced by this machine were withdrawn. Our Blue Bell team members recovered all involved products in stores and storage.

Five dead, 28 ill in 10 states, due to Listeria linked to prepackaged caramel apples

Multistate Outbreak of Listeriosis Linked to Commercially Produced, Prepackaged Caramel Apples

The FDA, CDC and state and local officials are investigating an outbreak of listeriosis potentially linked to commercially-produced, prepackaged caramel apples.  Investigators are working to identify the source of contamination and to determine what products may be contaminated.  New information will be provided as it becomes available.

Safety advisory posted after four deaths from HeartMate II® LVAS Pocket System Controller

Medical device not being recalled

After four deaths and five reports of loss of consciousness or other symptoms of hypo-perfusion, Thoratec Corporation initiated a voluntary worldwide medical device correction to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller (the “Pocket Controller”). This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. 

Why are jerky pet treats making them sick? Has your pet died as a result of jerky treats?

Rex was a rescue dog. This is his last day with us.

While serving overseas, we got our first German Shepherd, Rex. He was an older, gentle dog. We brought him home to the states with us. He filled our lives and hearts with happiness. 

We gave him jerky treats made in China then he started showing signs of pain. It broke our hearts to see him suffering as his body shut down. The vet said we needed to be unselfish and let him go. I held him and told him to go to sleep then carried him home and buried him.

Important safety label changes to cholesterol-lowering statin drugs

The FDA has made changes to the labels for cholesterol-lowering statin drugs. Patients need to be advised about possible serious problems that can happen when you are taking this medication.

Has your birth control been recalled?

Pfizer Inc. announces voluntary nationwide recall of birth control pills. Pfizer 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.

Information about the Tylenol, Sinutab, Benadryl, Rolaids recall

The U.S. Food and Drug Administration (FDA), and McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is recalling certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

Beetles found in Similac®-brand powder infant formula prompts recall

Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean are being recalled after the possibility of the presence of a small common beetle was found in the product.

Pet food is making our kids sick

Dry dog and cat foods have been linked to human illness reports the online medical journal Pediatrics, after conducting a study for a 3-year period. The investigation found human Salmonella, especially in young children.

The Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration investigated a multi-state outbreak of Salmonella infections in humans in 2007. They identified Salmonella bacteria in several brands of dry dog and cat food produced at a Mars Petcare US plant in Everson, Pa., including Pedigree and Special Kitty as the source.

Pet treats have also been recalled many times for Salmonella, and can make our kids sick.

FDA recalls due to health risk

Ventura Foods, LLC voluntarily recalls seven varieties of Its Dean's® Dip products as a precaution 

Ventura Foods, LLC is voluntarily recalling seven of its Dean’s® Dip products, with specific production dates, because a flavor enhancer may be contaminated with salmonella. The flavor enhancer is made by an ingredient supplier, Basic Food Flavors, Inc., in Las Vegas.

Philips issues recall of select Heartstart Fr2+ automated external defibrillators

Philips is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable.

Models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical, and manufactured between May 2007 and January 2008, are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED.

Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product 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 Web site.

Philips is offering a new FRx as your replacement device. It includes a free carry case, 1 set of pads, battery, and fresh 5-year warranty.

The HeartStart FRx is the newest member of the HeartStart family of defibrillators and it offers a host of valuable benefits. It is a smaller, lighter unit than FR2+ and it uses the same 1-2-3 layout of the FR2+. The FRx offers the same reliable SMART Analysis and SMART Biphasic therapy.

Learn how FRx is a great choice for FR2+ customers.

Exchange your affected unit for a new FRx, with free carry case, 1 set of pads, battery and fresh 5-year warranty.

Alternatively, you may replace your affected unit(s) with a refurbished FR2+ device that will carry the remainder of the warranty of your current device (approximately 3 years for most affected units). If you choose a refurbished FR2+ as a replacement device, no additional accessories will be provided.

Exchange your affected unit with a refurbished FR2+.

FDA warns consumers not to use stolen Albuterol and Ipratropium Bromide

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, are from one of the following lots:

• Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
• Lot number 9G04, NDC # 49502-697-29
• Lot number 9FD8, NDC # 49502-697-61
• Lot number 9FD9, NDC # 49502-697-61
• Lot number 9FE1, NDC # 49502-697-61
• Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
• Lot number F09089, NDC # 49502-685-31
• Lot number C09119, NDC # 49502-685-62
• Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Return products from these lots to the pharmacy where you received the medicine to exchange it for products from a different lot, or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

The FDA is asking for help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.