BMW IS RECALLS 2011 328I XDRIVE AND 335I XDRIVE VEHICLES

Vehicle Make / Model: Model Year(s): BMW / 328I 2011 BMW / 335I 2011 Manufacturer: BMW OF NORTH AMERICA, LLC Mfr's Report Date: SEP 15, 2011 NHTSA CAMPAIGN ID Number: 11V476000 N/A NHTSA Action Number: N/A

Component: POWER TRAIN:DRIVELINE:DRIVESHAFT

Potential Number of Units Affected: 190

Summary: BMW IS RECALLING CERTAIN MODEL YEAR 2011 328I XDRIVE AND 335I XDRIVE VEHICLES MANUFACTURED FROM FEBRUARY 8, 2011, THROUGH JULY 29, 2011. THE FRONT DRIVESHAFT ATTACHMENT BOLTS MAY NOT HAVE BEEN TIGHTENED TO SPECIFICATION. IF THE BOLTS WERE NOT TIGHTENED TO SPECIFICATION, THEY MAY BECOME LOOSE.

Consequence: IF THE BOLTS LOOSEN, IT COULD LEAD TO A LOSS OF POWER TO THE FRONT WHEELS AND ULTIMATELY A VEHICLE BREAKDOWN, INCREASING THE RISK OF A CRASH.

Remedy: BMW WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE FRONT DRIVESHAFT ATTACHMENT BOLTS FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING OCTOBER 2011. OWNERS MAY CONTACT BMW CUSTOMER RELATIONS AND SERVICES AT 1-800-525-7417.

Notes: OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

Quaker Oats Company, a division of PepsiCo, Recalls Quaker Chewy Smashbar Graham Pretzel snack bars

Quaker Oats Issues Voluntary Recall Of Specific 8-Count
Quaker Chewy Smashbar Graham Pretzel Snack Bars
Due To Undeclared Milk Allergen

Contact:
Consumer:
800-856-5781

Media:
Candace Mueller
312-821-2709
candace.mueller-medina@pepsico.com

FOR IMMEDIATE RELEASE - September 2, 2011 - Quaker Oats Company, a division of PepsiCo, has issued a voluntary recall of 8-count Quaker Chewy Smashbar Graham Pretzel snack bars due to an undeclared milk allergen that is not noted on the label. People who have an allergy or severe sensitivity to milk products run the risk of serious or life-threatening allergic reaction if they consume this product.

The affected product is limited to Quaker Chewy Smashbar Graham Pretzel snack bars with the UPC bar code ending in 31108 and best before dates: Oct 29 11 RB, Oct 30 11 MM, Oct 30 11 RB, Nov 22 11 RB, Nov 23 11 RB, Nov 24 11 RB, Nov 27 11 RB, Dec 22 11 RB, Dec 22 11 MM, Dec 23 11 RB, Dec 23 11 MM, Dec 24 11 RB, Dec 24 11 MM stamped on the side of the package. Consumers with a milk allergy who have this product in their possession should return it to the retailer where it was purchased for a full refund.

No other Quaker Chewy Smashbars, Quaker Chewy granola bars or Quaker products including the 40-count Quaker Chewy Smashbar variety pack sold at club stores are involved in this recall.

Quaker is in the process of recovering the product involved and is in contact with the Food and Drug Administration (FDA) to ensure the continued safety of those consumers who may be impacted by this issue.

This recall was initiated after it was discovered that the “may contain milk” disclaimer the product required was not included on the package. One allergic reaction has been reported to date in association with this product and the individual was treated immediately.

Consumers with questions or concerns about the recall of Quaker Chewy Smashbar Graham Pretzel granola bars should contact Quaker by calling the toll-free hotline at 800-856-5781.

FDA : Recall Arrow NextStep Antegrade Chronic Hemodialysis Catheter (Class 1 Recall)

Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

[Posted 08/03/2011]

AUDIENCE: Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. The affected products were manufactured between April 14, 2011 and May 9, 2011. See the Recall Notice for a listing of affected product and lot numbers.

BACKGROUND: The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck.

RECOMMENDATION: Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information.

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: www.fda.gov/MedWatch/report.htm
• 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

[08/03/2011 - Recall Notice - FDA]

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Teavana Recalls Peppermint Organic Herbal Tea Due To Salmonella Contamination

Contact:
Media Contact:
Alecia Pulman
203-682-8224
apulman@icrinc.com

Customer Inquiries:

Teavana CUSTOMER SERVICE

1-877-832-8262

FOR IMMEDIATE RELEASE - March 3, 2011 – Teavana Corporation today announced a voluntary recall of 2,659 lbs of Peppermint Organic Herbal Tea produced by Aromatics Inc., Basin City, WA, because it has the potential to be contaminated with Salmonella. Aromatics Inc. exclusively produces and distributes Teavana’s Peppermint Organic Herbal Tea. The recall was as the result of a batch sample testing program by the Company after it received a notification of possible contamination by the vendor, which revealed that the finished products contained the bacteria. The Company has ceased the production and distribution of the product as the FDA and the Company continue their investigation as to the origin of the contamination. 

Salmonella is 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. For more information on Salmonella, please visit the Centers for Disease Control and Prevention's Web site at http://www.cdc.gov or call 800-CDC-INFO (800-232-4636).

The Peppermint Organic Herbal Tea was distributed nationwide in Teavana retail stores and through mail and internet orders. The Peppermint Organic Herbal Tea is sold measured to customer’s orders in retail stores and sold in 2 oz pre-packaged pouches by mail order or internet. There are no lot/batch identifying markings on the store or ecommerce packaging. Retail store stock was sold between December 4, 2010 and February 16, 2011. Mail order & internet stock was sold between November 30, 2010 and February 16, 2011.

                 

While no illness related to this voluntary recall has been reported to date, any potential health risk is significantly reduced when following the printed brewing instructions on the package or available online.

Consumers who have purchased Peppermint Organic Herbal Tea are urged to return it to the place of purchase for a full refund. Consumers may also contact Teavana Customer Service at 1-877-832-8262 (M – F from 8.30 A.M. until 6:00 P.M., EST) for instructions on how to return the product.

Shaping Beauty, Inc. Recalls CELERITE™ SLIMMING CAPSULES

Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient

Contact:
Shaping Beauty
800-728-2850

FOR IMMEDIATE RELEASE - January 24, 2011 - Southampton, PA, Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:

CELERITE™ SLIMMING CAPSULES

The products listed above were sold and distributed nationwide via the internet at www.shapingbeauty.com

FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

No illnesses or injuries have been reported to the company to date in connection with this product. Shaping Beauty, Inc. has taken this action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Shaping Beauty, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to return the product to the company’s address in Southampton, PA Consumers with questions may contact Shaping Beauty, Inc. Monday through Friday 9:00 am to 5:30 pm at 1-800-728-2850

Any adverse reactions experienced with the use of this product should also 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, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm2.

American Regent Recalls Luitpold Pharmaceuticals' Sodium Thiosulfate Injection, USP.

American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A
Sr. Director of Professional Services
Phone: 631-924-4000

FOR IMMEDIATE RELEASE - February 3, 2011 -American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:  

Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial
NDC # 0517-1019-05
Lot #0056
Exp Date: January, 2012

PLEASE NOTE: This recall, initiated on February 2, 2011 to the User or Consumer Level, is for lot # 0056 Only. No other lots or sizes of Sodium Thiosulfate Injection, USP are subject to this voluntary recall.  

This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Sodium Thiosulfate Injection, USP is indicated in the treatment of cyanide poisoning.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent Inc., Sodium Thiosulfate Injection, USP, 10% (100mg/mL) 10 mL Single Dose Vial with lot # 0056 for patient care and should immediately quarantine any product for return. 

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email atpv@luitpold.com, by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

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

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

“All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients from any potential safety risks with our Sodium Thiosulfate Injection. The safety of patients receiving our products is our primary concern.” said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency. 

As is standard practice, and as stated in the Sodium Thiosulfate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

Sodium Thiosulfate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Source: Luitpold Pharmaceuticals, Inc.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Circle City Marketing and Distributing / Candy Dynamics Expands Recall To All Toxic Waste® Brand Nuclear Sludge® Products All Flavors And All Sizes Due To Elevated Levels Of Lead

Candy Dynamics Expands Recall To All Toxic Waste® Brand Nuclear Sludge®
Products All Flavors And All Sizes

Contact:
Laura King
888-400-7606

FOR IMMEDIATE RELEASE - January 27, 2010  - Circle City Marketing and Distributing, doing business as Candy Dynamics, Indianapolis, IN, is issuing a voluntary recall of all Toxic Waste® brand Nuclear Sludge® products, all flavors, 0.3 oz (8 g) size pieces. The product is imported from Pakistan.

On January 13, 2011, the company previously recalled Toxic Waste Brand® Nuclear Sludge®, Net wt. 0.7 oz (20g) size, all flavors. With this recall of the smaller piece size, the company has now recalled all products labeled as "Nuclear Sludge®".
Further testing by the company indicates that while some of the smaller sized products were below the FDA limit, some contain elevated levels of lead (0.101 parts per million to .311 ppm; the U.S. FDA tolerance is 0.1 ppm) that potentially could cause health problems, particularly for infants, small children, and pregnant women.
The company has determined to recall all lots and all flavors of the smaller sized product distributed from the product's inception in May 2009 through January 2011.
The smaller sized products are identified as: Toxic Waste® Nuclear Sludge® Cherry (UPC 0 89894 81901 1), Toxic Waste® Nuclear Sludge® Green Apple (UPC 0 89894 81701 7), and Toxic Waste® Nuclear Sludge® Blue Raspberry (UPC 0 89894 81801 4). Each individual piece has a net wt. of 0.3 oz (8 g) and were sold individually, as part of a 'Party Bag’ or Membership kit, and packed in 30 ct., 80 ct., and 120 ct. bags and a 120 ct. fishbowl.
No other "Toxic Waste®" brand product, besides those labeled "Nuclear Sludge®" is affected by this recall.
No illnesses have been reported to date in connection with this problem.
The recalled Nuclear Sludge® products were distributed nationwide in retail stores and through mail orders. The product was also distributed in Canada and in very limited quantities in Guatemala, Ireland, Jordan, Korea, Mexico and El Salvador.
The company is discontinuing the sale of Nuclear Sludge® products in the U.S.
Candy Dynamics is sending recall notices to its direct customers. Anyone in possession of the recalled product should telephone the company for information on destruction of the product. Please call Eileen O’Neal at 317-228-5012 (Monday - Friday 9am - 5pm EST) for further information.

Keebler® Recalls Fudge Shoppe® Jumbo Fudge Sticks

KEEBLER ISSUES ALLERGY ALERT ON MISLABELED 8-COUNT CARTONS OF FUDGE SHOPPE® JUMBO FUDGE STICKS SOLD AT CONVENIENCE STORES

 

Media Contact:
Media Hotline
269-961-3799

FOR IMMDIATE RELEASE - BATTLE CREEK, Mich., Jan. 27, 2011 – Keebler® is recalling a limited quantity of 8-count cartons of Fudge Shoppe® Jumbo Fudge Sticks sold at convenience stores. This recall was initiated because the cartons contain individually wrapped Jumbo Peanut Butter Sticks. The individually wrapped cookie sticks are correctly labeled.

People who have allergies to peanut run the risk of serious or life-threatening allergic reactions. Because the individually wrapped cookie sticks contain peanuts, consumers with peanut allergies should avoid eating this product.

Approximately 17,000 8-count cartons of the recalled product were distributed to brokers and convenience stores in the U.S. They are marked with UPC Code 3010053332 and a lot code of AS 07 27 1A.

No allergic reactions have been reported to date.

Consumers with questions or who would like a replacement may contact the Keebler Consumer Response Center at 888-746-3679 from 8 am to 8 pm Eastern time, or visit www.Keebler.com.

FDA

Do Not Use Triad Alcohol Prep Pads Packaged With Pfizer Inc. and Progenics Pharmaceuticals, Inc RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection.

PFIZER INC. AND PROGENICS ALERT PHYSICIANS AND PATIENTS TO INFORMATION RELATED TO TRIAD GROUP ALCOHOL PREP PRODUCTS INCLUDED IN U.S. RELISTOR KIT PACKAGING

Pfizer Contact:
Rick Chambers
(269) 833-6387

Progenics Contact:
Amy Martini
(914) 789-2816

FOR IMMEDIATE RELEASE - January 25, 2011 - NEW YORK, N.Y. and TARRYTOWN, N.Y. – Pfizer Inc. and Progenics Pharmaceuticals, Inc. have learned of a United States market recall of alcohol prep pads and swabs manufactured by the Triad Group. In the interest of patient safety, Pfizer and Progenics are alerting U.S. patients and physicians to Triad’s recall. Triad® Alcohol Prep Pads are packaged for use with the kit presentation of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.
Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their RELISTOR injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.
Shipments of RELISTOR kits have been suspended until the alcohol pads can be replaced, which will be done as quickly as possible to enable patients to continue to receive RELISTOR. Triad alcohol prep products are not included in RELISTOR sold as single vials or in RELISTOR kits outside of the United States or with other Pfizer medications.
The following information about the recall of Triad alcohol prep products is available on the U.S. Food and Drug Administration’s web site: Triad press release: http://www.fda.gov/Safety/Recalls/ucm239219.htm Safety information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.
Patients with questions about RELISTOR should consult their pharmacist or healthcare provider, or call Pfizer Medical Information at 1-800-438-1985. RELISTOR is manufactured and marketed by Pfizer under a licensing agreement with Progenics.
About RELISTOR
RELISTOR Subcutaneous Injection is approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied. The drug is also approved for use in over 50 countries worldwide, including in the European Union, Canada, Australia and Brazil. Applications in additional countries are pending. In the 27 member states of the E.U., as well as Iceland, Norway and Liechtenstein, RELISTOR is approved for the treatment of OIC in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. In Canada, the drug is approved for the treatment of opioid-induced constipation in patients with advanced illness, receiving palliative care. When response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. RELISTOR is the brand name under which methylnaltrexone is marketed outside Japan by Wyeth, a wholly-owned subsidiary of Pfizer.

Important Safety Information for RELISTOR

• RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction
• If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician
• Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients. Use RELISTOR with caution in patients with known or suspected lesions of the GI tract
• Use of RELISTOR has not been studied in patients with peritoneal catheters
• The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%)
• Safety and efficacy of RELISTOR have not been established in pediatric patients RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com. (PGNX-G)

FDA

PEEKAY INTERNATIONAL INC. Recalls SWAN GOLDEN RAISINS

PEEKAY INTERNATIONAL INC. ISSUES ALLERGY ALERT ON UNDECLARED SULFITES IN SWAN GOLDEN RAISINS

Contact:
MRS. MAYURI MEHTA, SAGAR MEHTA
TEL 718-366-6100


FOR IMMIDIATE RELEASE– January 26, 2011 - PEEKAY INTERNATIONAL INC. is recalling SWAN GOLDEN RAISINS because they may contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume these products.
The recalled SWAN GOLDEN RAISINS are packaged in uncoded, clear plastic bags in 7.0 oz and 14.0 oz sizes. They were sold in the Brooklyn and Queens areas of New York City.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by food laboratory personnel revealed the presence of undeclared sulfites in SWAN GOLDEN RAISINS in 7.0 oz and 14.0 oz packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfites sensitive individuals upon ingesting 10 milligrams or more of sulfites.
No illnesses have been reported to date in connection with this problem.
Consumers who have purchased SWAN GOLDEN RAISINS should return the product to the place of purchase. Consumers with questions may contact the company at 718-366-6100

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