GA

Make sure you know about all recalls & keep your family safe, Subscribe Free via email

Enter your email address Or Click on FeedBurner Icon (Right) to subscribe via Your News Reader. Your Email is never shared:

Delivered by FeedBurner

Tuesday, January 22, 2013

Advance Pharmaceutical Recalls Rugby Ferrous Sulfate Tablets


Advance Pharmaceutical Issues Nationwide Voluntary recall of one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets

Contact:
Consumer:
Advance Pharmaceutical Inc.
Ph: 631-981-4600, Ext. 300
 
FOR IMMEDIATE RELEASE - January 17, 2013 - Advance Pharmaceutical Inc. today announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate. Advance Pharmaceutical Inc. initiated the recall on December 28, 2012 because they received a pharmacist complaint that a bottle of Ferrous Sulfate Tablets, 325 mg 07-2014, contained Meclizine HCl 25 mg tablets, NDC 0536-3990-01. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.
Consumers who take three tablets daily of the defective product for treatment of iron deficiency will would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alterness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.
Consumers who have the affected lot may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300 on Monday through Friday between 8:30 am and 4:30 pm ET.
Adverse reactions 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.
###
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.

Mitosol® (mitomycin for solution) Recalled By Mobius Therapeutics, LLC, FDA


Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin for
solution), 0.2 mg/vial, Kit for Ophthalmic Use

Contact:
Consumer:
1-877-393-6486
Mobius Web Site
FOR IMMEDIATE RELEASE - January 10, 2013 - Mobius Therapeutics, LLC, St. Louis, MO, announced today that it is conducting a voluntary recall of 2 lots of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use.  The company is taking this voluntary action due to the fact that we cannot exclude the possibility that the affected lots may be non-sterile.  These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use.
Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6486, Option 2, for safe return of the product.
The impacted product is identified below:
NDC #Lot #Exp DateProduct Description
49771-002-01M09826008/2013Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use
49771-002-01M08692008/2013Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use
These lots were distributed in the following states:
AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, & WI
between the dates of 10/22/2012 and 12/14/2012.
Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.
Mobius has contacted all affected customers by phone call, e-mail and written notification and they are arranging for return of unused product and replacing with product from unaffected lots.
Questions may be directed to Mobius by dialing 1-877-EYE-MITO (1-877-393-6486) and pressing option “2”, Monday to Friday, 8:00 am to 5:00 pm CST. Adverse reactions 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.
  • 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Monday, May 14, 2012

Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California

Signage is posted in affected Whole Foods Market stores to notify customers of this recall. The necessary corrections have been made for the cupcake six-packs currently for sale. Consumers who have purchased the affected products from Whole Foods Market may return it to the store for a full refund. Consumers with questions should contact their local store.

Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California
Contact:Media:
Libba Letton
libba.letton@wholefoods.com
FOR IMMEDIATE RELEASE - May 11, 2012 - Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Whole Foods Market cupcake six-packs sold in Northern California included several flavors of cupcake, including chocolate, red velvet, and vanilla in addition to carrot cake. Only the carrot cake cupcakes contain walnuts. Six-packs that do not contain carrot cake cupcakes are NOT affected by this recall.
The recalled cupcakes were sold at stores in Folsom, Lafayette, Los Altos, Mill Valley, Novato, Palo Alto, San Francisco, San Jose, Santa Rosa and Sonoma.
The cupcake six-packs came in clear, plastic clamshell containers. The recall includes all expiration packed on dates prior to May 10th 2012. Customers who have purchased these products may return them to the store for a full refund.
Signage is posted in affected Whole Foods Market stores to notify customers of this recall.
The necessary corrections have been made for the cupcake six-packs currently for sale.
Consumers who have purchased the affected products from Whole Foods Market may return it to the store for a full refund. Consumers with questions should contact their local store.

Hospira Recalls Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Hospira Announces A Nationwide Voluntary Recall Of One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
Contact:Consumer:
Hospira Medical Communications
1-800-615-0187
Media
(224) 212-2357
FOR IMMEDIATE RELEASE - May 12, 2012 - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume.
Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL. The expiration date is July 1, 2013.
The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients.
Hospira has not received any reports of adverse events related to this issue for this lot. Hospira has initiated an investigation to determine the root cause and preventive actions. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Events Program either online, buy regular mail or by fax.
  • Fax:
  • 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).About HospiraHospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com

Friday, September 23, 2011

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 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 .

Saturday, September 3, 2011

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.

Wednesday, August 3, 2011

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]

-
-