Tuesday, January 22, 2013
solution), 0.2 mg/vial, Kit for Ophthalmic Use
|NDC #||Lot #||Exp Date||Product Description|
|49771-002-01||M098260||08/2013||Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for|
|49771-002-01||M086920||08/2013||Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for|
Monday, May 14, 2012
Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California
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 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
Hospira Medical Communications
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.
- Regular mail:use postage-paid, pre-addressed Form FDA3500 available at www.fda.gove/MedWatch/getforms.htm
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
|Component: POWER TRAIN:DRIVELINE:DRIVESHAFT|
|Potential Number of Units Affected: 190|
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.
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.
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.
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
Wednesday, August 3, 2011
Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall
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]