Physio-Control, Inc.

11811 Willows Road NE

Redmond, Washington 98052-2003

Product(s): LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors

Physio-Control notification and instructions to search for affected devices by serial number.

The serial number is located on the underside of the device and contains only numbers.

The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.

A failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

Public Contact: Physio-Control Technical Support at rs.sealifepaksupport-usa@medtronic.com or call 1-800-442-1142, Monday – Friday between 6:00 A.M. and 4:00 P.M. (Pacific Time).

The firm began mailing notification letters to affected customers on May 26, 2010. All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

FDA release

McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP  (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.  The odor is caused by the presence of a chemical   2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.

see press release below

Fort Washington, PA – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.  The recall is being expanded, as a precaution, to include all TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.   For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet atwww.tylenol.com.  Consumers who have medical concerns or questions should contact their healthcare provider.  Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected TYLENOL® Arthritis Pain Caplet 100 count product lot numbers can be found on the side of the bottle label. See the full list of affected product lot numbers below:

Recalled Product- Full List (LINK: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc)

The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries:  the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action.  The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product.  These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

This lot number is listed on both the outer carton and the bottle.  Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday – Friday, 9AM – 6PM US ET, Saturday – Sunday, 9AM – 4PM US ET)

From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

Englewood Cliffs, NJ, December 2009 – Unilever United States, Inc., in cooperation with the U.S. Food and Drug Administration (FDA), is conducting a nationwide voluntary recall of all Slim-Fast® ready-to-drink (RTD) products in cans, due to the possibility of contamination with Bacillus cereus, a micro-organism, which may cause diarrhea and possibly nausea and/or vomiting. The probability of serious adverse health consequences is remote.

Slim-Fast Recall

The products were sold in stores nationwide.

Product Description:

The products are packaged in paperboard cartons and contain four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. A listing of all RTD recalled products is attached to this press release.

No other Slim-Fast® products are affected by this recall. No Slim-Fast® powdered shakes, meal bars, or snack bars are affected by this recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Out of an abundance of caution, the company is recalling all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. The company is in the process of identifying and correcting the production issue, and will resume production and shipment of the product when the issue has been addressed and corrected.

Consumers who have purchased Slim-Fast® RTD products in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open Monday – Friday, 8:30 AM – 6:00 PM ET. A recorded message is available 24/7.

 Davis, CA – November 22, 2009 – Timco Worldwide Inc. is recalling a limited number of its Large Seedless Watermelons because they have the potential to be contaminated with Salmonella. No illnesses have been reported to date in connection with this occurrence. Salmonella is an organism that 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. The Large Seedless Watermelons included in this voluntary recall were distributed to select grocers, wholesalers and processors in California and Texas. The Large Seedless Watermelons are stickered with the “MelonUp!” label with the PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6. The potential for contamination was noted after routine testing, by a distribution company, which revealed the presence of Salmonella on the outside rind of a melon randomly selected for testing. Timco Worldwide Inc. elected to exercise an abundance of caution and initiate the recall in the interest of public health. No illnesses have been reported to date in connection with this occurrence. Consumers who have purchased Large Seedless Watermelons in the markets noted above (with the MelonUp! label) are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-530-757-1000 press “4” for Food Safety. (Hours of business: Monday through Friday 8AM to 5PM PST). As with all fresh fruits and vegetables, Timco Worldwide Inc recommends that fresh melons are washed before cutting and/or consuming them.

Jelly Belly Issues Allergy Alert on Undeclared Peanuts in 7.5oz cylinder-style packages of 49 Flavors Jelly Belly jelly beans

 FOR IMMEDIATE RELEASE – Fairfield, Calif. – November 4, 2009 — Jelly Belly Candy Company is recalling 7.5-ounce cylinder-style packages of 49 Flavors Jelly Belly jelly beans because the package is incorrectly labeled. The mislabeled packages failed to list peanut butter and peanut flour in the ingredient statement. People who have an allergy to peanuts or a severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these ingredients.

Jelly Belly 49 Flavors Jelly Bean - Peanut Allergy Alert

The Jelly Belly 49 Flavors cylinder packages were shipped to approximately 200 independent stores nationwide from September 29 to October 30, 2009. Product was packaged in a clear 7.5-ounce acetate cylinder with white label on the bottom of the package with lot codes 090925, 090928, 090929 or 091001. UPC code 071567989398

The recall was initiated after the company’s quality control efforts identified the incorrect ingredient statement. No illnesses or allergic reactions have been reported to date.  No other candies or packaged candies from Jelly Belly are a part of this recall, and there is no health risk for consumers who are not allergic to peanuts.

Consumers who have a peanut allergy and purchased this product in the last five weeks are urged to return it to Jelly Belly Candy Company, One Jelly Belly Lane, Fairfield, Calif., 94533. Consumers and retailers with questions about the recall should call the Jelly Belly Hotline at 800-522-3267 Monday-Friday 7 am to 5 pm PST

If you or anyone you know has had an allergic reaction to these Jellybeans, please contact us. http://www.eichenlevinson.com/contact.cfm

 Company Contact:
1-866-236-8417
service@bodybuilding.com

Boise, ID – November 3, 2009 – As part of its ongoing cooperation with the Food and Drug Administration (“FDA”), Bodybuilding.com, LLC (the “Company”) announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the “Recalled Products”) described on the attached list, that were sold through the Company’s website, www.bodybuilding.com.

The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” While the Company has not had an opportunity to independently confirm the FDA’s concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

The Company has not received to date any reports of adverse events in connection with the Recalled Products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with the FDA to conduct a recall of the products the FDA has identified as containing steroids. Prior to agreeing to carry the Recalled Products, the Company received assurances from all of the manufacturers of the Recalled Products that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient. Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.

Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postagepaid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].

The Company is committed to providing accurate information about its products. The Company is working voluntarily with the FDA in this recall process.

Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.

 RECALLED PRODUCT LIST

 Brand Name

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge 

Ergopharm 6-OXO 

Ergopharm 6-OXO Extreme 

EST (aka Engineered Sports Technology) MethAnstance 

Extreme Labs Susto-Test Depot 

Fizogen ON Cycle II Hardcore 

G.E.T/ (Genetic Edge Technologies) SUS-500 

G.E.T/ (Genetic Edge Technologies) Tren-250 

Hardcore Formulations T-Roid 

I Force Nutrition 1,4 AD Bold 200 

I Force Dymethazine/Reversitol Combo Pack 

I Force Reversitol 

I Force Nutrition 17a PheraFLEX 

I Force Nutrition Dymethazine 

I Force Nutrition Methadrol 

IDS (aka Innovative Delivery Systems) Bromodrol 

IDS (aka Innovative Delivery Systems) Grow Tabs TR 

IDS (aka Innovative Delivery Systems) Mass Tabs 

IDS (aka Innovative Delivery Systems) Oxodrol Pro 

IDS (aka Innovative Delivery Systems) Ripped Tabs TR 

IDS (aka Innovative Delivery Systems) Rapid Release 

Ripped Tabs 

Kilo Sports Massdrol 

Kilo Sports Phera-Mass 

Kilo Sports Trenadrol 

Monster Caps Monster Caps 

Myogenix Spawn 

Nutra Coastal D-Stianozol 

Nutra Coastal H-Drol 

Nutra Coastal MDIT 

Nutra Coastal S-Drol 

Nutra Coastal Trena 

Performance Anabolics Methastadrol 

Performance Anabolics Tri-Methyl X 

Purus Labs E-pol Inslinsified 

Purus Labs Nasty Mass 

Rage RV2 

Rage RV3 

Rage RV4 

Rage RV5 

Redefine Nutrition Finaflex 550-XD 

Redefine Nutrition Finaflex Ripped 

Transform Supplements Forged Extreme Mass 

Transform Supplements Forged Lean Mass

 - October 27, 2009 – Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• • Online:www.fda.gov/medwatch/report.htm
  • Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178

Contact:
Kate Sobel
Email: press@plumorganics.com
Phone: 646.416.6446

FOR IMMEDIATE RELEASE – October 19, 2009 – Emeryvillle, CA – Plum Organics ™ announced today that it is taking the precautionary measure of voluntarily recalling one particular batch of its 4.22oz. Apple & Carrot Portable Pouch baby food with the best by date May 21, 2010 and marked with the following universal product code (UPC) #890180001221 located on the bottom of the package. These pouches are sold individually at Toys-R-Us and Babies-R-Us locations nationally.

No illnesses have been reported in connection with this product and no other Plum Organics products are affected. As a further precaution, samples from every Plum Organics product manufactured before and after this batch were tested and found to be within quality standards.

The recall was undertaken as a precaution due to the risk of potential contamination with Clostridium botulinum, which can cause botulism, a serious and sometimes lifethreatening condition. Consumers should not use these products, even if they appear to be normal, because of the possible health risk. Symptoms of botulism poisoning in humans include general weakness, dizziness, double-vision and trouble with speaking or swallowing. People experiencing these problems should seek immediate medical attention.

“The product did not meet the FDA guidelines for proper acidity level,” said Dr. Paul Gerhardt, a Food Science Ph.D. and member of the Plum Organics action team. “Though the risk of illness from this one batch is minimal, Plum Organics is taking the extraordinary step of recalling all Apple & Carrot Baby Food Pouches with best by date May 21, 2010.”

“As a mother, the safety and satisfaction of our customers and their children is my highest concern,” said Plum Organics Founder Gigi Lee Chang. Due to a mixing error during production, one batch of this product was improperly blended. As a result, it did not meet our company’s standard for quality. We are taking the extra step of recalling all Apple & Carrot Portable Pouches with this date to eliminate any question in the minds of consumers about the safety of our products. Plum Organics was founded on the vision of superior quality and nutritious baby food; we are committed to these values and our consumers.”

Consumers who have purchased the Plum Organics Apple & Carrot pouch-based baby food with a best by date May 21, 2010 and with the UPC # 890180001221 can return the product for a full refund at any Toys-R-Us or Babies-R-Us store.

The recall is being undertaken with the knowledge of the U.S. Food & Drug Administration.

Consumers with any questions are asked to call 888-974-3555 between the hours of 8 am – 5 pm PST, or email info@plumorganics.com.

Plum Organics is the leading premium organic baby food brand in the nation.

If you or someone you know has been the victim of a mis-administered drug, contact http://www.eichenlevinson.com/

Relenza (zanamivir) Inhalation Powder

GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.