I just saw this Recall notice and thought I would share it with you:

LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen “milk”, in the whey powder listed in their ingredient statements. People who have an allergy or severe sensitivity to milk run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume these products.

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall – Particulate Matter In Vials

[Posted 05/21/2013]

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Clinical symptoms are not to be expected from these
microemboli and Sandoz is not aware of any reports of related adverse events.

BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).

RECOMMENDATION: In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@sandoz.com.

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

[05/20/2013- Firm Press Release - Sandoz]

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

The side mattress support rails on panel, loft and bunk beds can break.

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Notice originally published courtesy of [ Consumer Product Safety Commission ]

I just saw this Recall notice and thought I would share it with you:

Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Abbott Diabetes Care: Class 1 Recall – FreeStyle InsuLinx Blood Glucose Meters – Risk of Incorrect Test Result

 

[Posted 05/20/2013]

AUDIENCE: Risk Manager, Patient, Health Professional

ISSUE: Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention.

BACKGROUND: The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels. On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter to all its affected customers. The FreeStyle InsuLinx Blood Glucose Meters were distributed from April 18, 2012 through April 1, 2013.

RECOMMENDATION: Consumers who are using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with your meter:

• Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.
• Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.

Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits are advised to immediately discontinue dispensing them to your patients, and to arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697.

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

 

[05/20/2013 - Recall Notice - FDA]
[04/15/2013 - Firm Press Release - Abbott]

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free.

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers.

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Dated: APR 18, 2013 Forest River is recalling certain model year 2013-2014 Forest River models Blue Ridge, Cardinal, Cherokee, Columbus, EVO, Georgetown, Flagstaff, Forester, Lexington, Puma, Rockwood, Sabre, Salem, Sand…

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Notice originally published courtesy of [ National Highway Traffic Safety Administration ]

I just saw this Recall notice and thought I would share it with you:

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall – Lack Of Sterility Assurance

[Posted 05/18/2013]

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.

BACKGROUND: In April 2013, NuVision recalled Methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection. The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the Methylcobalamin injection product that was previously recalled.

RECOMMENDATION: For all sterile products from NuVision, the FDA recommends that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision sterile products, quarantine those products, and not administer them to patients. Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their health care provider.

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

[05/18/2013 - News Release - FDA]

Previous MedWatch Alert:
[04/16/2013 - MedWatch Safety Alert - FDA]

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Notice originally published courtesy of [ Food and Drug Administration ]

I just saw this Recall notice and thought I would share it with you:

Dated: APR 18, 2013 Forest River is recalling certain model year 2013-2014 Forest River models Blue Ridge, Cardinal, Cherokee, Columbus, EVO, Georgetown, Flagstaff, Forester, Lexington, Puma, Rockwood, Sabre, Salem, Sand…

If you need help acting on this recall notice please come chat with me and I will walk you through what to do next. Register at http://takeclassaction.com

Notice originally published courtesy of [ National Highway Traffic Safety Administration ]