The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: HVAD Pump Implant Kit Models: 1101, 1103, 1104, 1104JP, MCS1705PU Distribution Dates: October 11, 2006 to June 3, 2021 Devices Recalled in the U.S.: 1,614…
Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring
Image Español As we get older, we can develop new growths on our skin that we may consider unattractive. These lesions are parts of the skin that look abnormal and include moles, seborrheic keratoses (wart-like growths), and skin tags. Removing them isn’t a do-it-yourself project, and it can be dangerous to try. Please see a…
Prairie City Bakery Recalls Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes Because of Possible Health Risk
Summary Company Announcement Date: June 08, 2022 FDA Publish Date: June 08, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Due to potential for Salmonella contamination Company Name: Prairie City Bakery Brand Name: Brand Name(s) Prairie City Bakery Product Description: Product Description Peanut Butter Chocolate Chip Ooey Gooey Butter Cake Company…
Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
Summary Company Announcement Date: June 08, 2022 FDA Publish Date: June 08, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination Company Name: Plastikon Healthcare, LLC Brand Name: Brand Name(s) Plastikon Healthcare, LLC Product Description: Product Description Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Company Announcement FOR IMMEDIATE RELEASE…
FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On May 20, 2022, the FDA approved azacitidine (brand name…
F&S Fresh Foods Recalls 7.25oz Garden Highway Snacks Brand Protein Power Snack (UPC 8 26766 00979 4) Because of Possible Health Risk
Summary Company Announcement Date: June 07, 2022 FDA Publish Date: June 07, 2022 Product Type: Food & Beverages Peanut Butter Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: F&S Fresh Foods Brand Name: Brand Name(s) Fresh Garden Highway Product Description: Product Description Protein Power Snack Company Announcement F&S Produce Co of Vineland,…
Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination
Summary Company Announcement Date: June 07, 2022 FDA Publish Date: June 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains elevated levels of Bacillus cereus Company Name: Buzzagogo Inc. Brand Name: Brand Name(s) Allergy Bee Gone for Kids Product Description: Product Description Nasal Swab Remedy Company Announcement FOR IMMEDIATE RELEASE –…
Ukoniq (umbralisib): Drug Safety Communication – FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns
[Posted 06/01/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, the FDA determined the risks of treatment with Ukoniq…
Taharka Brothers Ice Cream Recalls Peanut Butter Cup Ice Cream Because of Possible Health Risk
Summary Company Announcement Date: June 06, 2022 FDA Publish Date: June 06, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Salmonella Company Name: Taharka Brothers Ice Cream Brand Name: Brand Name(s) Taharka Brothers Product Description: Product Description Peanut Butter Cup Ice Cream Company Announcement Taharka Brothers Ice Cream of Baltimore, Maryland…
Wilton Brands Issues Allergy Alert on Possible Presence of Undeclared Milk in Two Sprinkle Products
Summary Company Announcement Date: June 02, 2022 FDA Publish Date: June 06, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Wilton Industries, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rainbow Chip Crunch Sprinkles and Rainbow Sprinkles Mix Company Announcement NAPERVILLE, Ill., June 2, 2022 (GLOBE…