Busse Hospital Disposables Issues Nationwide Recall of Kits/Trays Containing Sterile Water Based Products Under Recall by Nurse Assist

Summary Company Announcement Date: December 19, 2023 FDA Publish Date: December 20, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Lack of Sterility Company Name: Busse Hospital Disposals Brand Name: Brand Name(s) Busse Hospital Disposals Product Description: Product Description Medical Device Kits and Trays Company Announcement…

Beware of Illegally Marketed Diabetes Treatments, Fraudulent Pharmacies

Image Español As the number of people diagnosed with diabetes continues to grow, an increasing number of products marketed under the guise of “dietary supplements” or “over-the-counter drugs” promising to prevent, treat, and even cure diabetes are being sold illegally. The U.S. Food and Drug Administration advises consumers not to use such products – for…

InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

Summary Company Announcement Date: December 09, 2023 FDA Publish Date: December 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to seal integrity issues allowing for powder leakage from the pouch. Company Name: InvaGen Pharmaceuticals Inc. Brand Name: Brand Name(s) Product Description: Product Description Vigabatrin for Oral Solution, USP 500mg Company Announcement…

Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive

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 Names: CARDIOHELP Emergency Drive Product Codes: See Recall Database Entry Model Numbers: 701048002, 701076205 Manufacturing Dates: August 11, 2022 through June 20, 2023 Distribution Dates: September…

Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays

Summary Company Announcement Date: December 07, 2023 FDA Publish Date: December 07, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of sterility assurance which could result in non-sterile product Company Name: Cardinal Health Brand Name: Brand Name(s) Covidien and Cardinal Health Product Description: Product Description Urology and OR room specific…

Flour Is a Raw Food and Other Safety Facts

Image Español​ You may not realize it, but most flour is a raw food. And it hasn’t been treated to kill any bacteria (germs) it may contain. Cooking and baking is what kills any bacteria in flour, as well as in raw eggs that are often used with it. To stay safe, don’t eat or…

Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction

[Posted 11/28/2023] AUDIENCE:  Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy  ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction…

BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy

[Posted 11/28/2023] TOPIC: BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy AUDIENCE: Patient, Health Professional, Risk Manager, Oncology, Pharmacy ISSUE: The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous…