FDA News

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s Read More (external link)...

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Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation. Read More (external link)...

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United Natural Trading LLC Announces Allergy Alert for Undeclared Milk in Fresh Direct Dark Chocolate Covered Pretzels

January 29, 2025 – United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due to the presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction Read More (external link)...

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Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results

StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records. Read More (external link)...

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Wismettac Asian Foods Issues Allergy Alert on Undeclared Milk in Curvee Puffs Corn Puff Snack

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is expanding its January 17, 2025 recall of 2.46 oz packages of Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor. The expansion now includes two additional flavors; Sea Salt & Umami Flavor and Corn Potage Flavor. The product contains the und Read More (external link)...

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New York Wholesale Group Recalls Zaarah Herbals Shatavari Powder Because of Possible Health Risk

New York Wholesale Group of Hicksville, NY is recalling Zaarah Herbals Shatavari Powder, to the consumer/user level because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increase Read More (external link)...

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