BAK-EZ Bakery Company of Norcross, Georgia is recalling 7-Eleven 4.0 oz. Mantecada (Muffin) (SKU 9841) (UPC 05254859241-7) because it may contain undeclared “milk” in the allergen statement. People who have an allergy or severe stativity to Milk they run the risk of serious or life-threatening allergic reaction if they consume this product. UPC Pack/Size Brand…
A&H Focal Inc. Issues Nationwide Recall of 21 Products Marketed as Dietary Supplements & One Cosmetic Product Due to the Possible Presence of Undeclared Erectile Dysfunction Ingredients
A&H Focal Inc. is voluntarily recalling all lots of the following products because many of these products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e. sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making these tainted dietary supplements unapproved drugs….
March 9, 2017: Internet Business Owner Indicted for Selling Non-FDA Approved and Misbranded Versions of Botox and Juvederm Related Products
LAS VEGAS, Nev. – The owner and operator of numerous beauty product websites was arrested and charged in a 25-count indictment for selling misbranded drugs and misbranded medical devices, announced U.S. Attorney Daniel G. Bogden for the District of Nevada and Special Agent in Charge William Conway for the FDA Office of Criminal Investigations’ Chicago…
FDA’s Food and Cosmetic Information Center Answers Your Questions
Get Consumer Updates by email. I heard about a recall of a fruit or vegetable that’s been associated with foodborne illness. How do I know if the produce in my refrigerator is implicated since there are no labels or lot numbers? My friend told me about an herbal supplement that…
Nonna Foods Issues Allergy Alert on Undeclared Milk in Lidia’s Marinara Sauce
Nonna Foods in Woodbury, New York, is voluntarily recalling 25 ounce jars labeled as Lidia’s Marinara Sauce bearing a Best By Date 06/13/2019, because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication
[Posted 03/09/2017] AUDIENCE: Surgery, Infectious Disease, Transplantation, Risk Manager ISSUE: On Dec. 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea and Enterococcus…
FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication
Date Issued: March 9, 2017 Audiences: Organ and tissue procurement organizations Organ and tissue transplantation centers Health Care Providers who conduct organ and tissue transplant procedures Health Care Providers who care for organ and tissue transplant recipients Operating Room Managers, Directors and Staff Risk Managers Patients considering organ or tissue transplantation Organ and tissue recipients…
Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication
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FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication
Date issued: March 8, 2017 Audiences: Health care providers who manage the care of patients with autonomic dysfunction, including neurologists, interventionalists (radiologists, vascular surgeons, and neurosurgeons), and clinical researchers People considering treatment options for autonomic dysfunction, including but not limited to Parkinson’s disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral…
Class I Medical Device Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly
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