Summary Company Announcement Date: June 09, 2022 FDA Publish Date: June 09, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination identified as Providencia rettgeri. Company Name: Green Pharmaceuticals Inc Brand Name: Brand Name(s) Product Description: Product Description Nasal spray Company Announcement FOR IMMEDIATE RELEASE – June 09, 2022 –…
Mezclar medicamentos y suplementos dietéticos puede poner en peligro su salud
Image English Cuando usted toma medicamentos recetados o de venta libre, ¿también toma una vitamina, mineral u otro suplemento dietético? ¿Ha considerado la posibilidad de que exista algún peligro al mezclar medicamentos y suplementos dietéticos? Puede haberlo. Algunos suplementos dietéticos pueden modificar la absorción, el metabolismo o la excreción de un medicamento. Si esto ocurre,…
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
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…
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…
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…
Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
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: iCast Covered Stent Product Lot Numbers: See recall database entry Distribution Dates: December 31, 2018, to March 31, 2022 Devices Recalled in the U.S.: 68,812…
Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
June 2, 2022 The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq, next generation sequencing instruments. These instruments are medical devices that may be specified either for…