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: Viral Transport Media Containers Brand names HXBL, WETEX, or Genesis Biomedical, with part numbers HX-K59, HX-K59-1, and “custom made” (saline). Product Serial Numbers: Distribution Dates:…
VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination
Summary Company Announcement Date: August 04, 2022 FDA Publish Date: August 04, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution Company Announcement Vi-Jon, LLC is revising a…
Plastikon Healthcare Expands 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: August 03, 2022 FDA Publish Date: August 04, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Plastikon Healthcare, LLC Brand Name: Brand Name(s) Product Description: Product Description Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Company Announcement 8/3/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC…
Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: August 01, 2022 FDA Publish Date: August 02, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: Distributor RFR, LLC Brand Name: Brand Name(s) Product Description: Product Description SANGTER Energy Supplement, 3000mg Company Announcement 08/01/2022 – Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656,…
North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA
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: Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit, may also be called: Oral Rapid Test or Oral Rapid Antigen Test Lateral Flow COVID 19 Rapid Antigen…
FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor
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 July 14, 2022, the FDA approved crizotinib (brand name…
Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene
Summary Company Announcement Date: July 29, 2022 FDA Publish Date: July 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of benzene Company Name: Edgewell Personal Care Company Brand Name: Brand Name(s) Banana Boat Product Description: Product Description Hair & scalp sunscreen spray Company Announcement SHELTON, Conn., July 29, 2022…
Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub 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 Names: Palindrome and Mahurkar Hemodialysis Catheters Product Codes: MSD Model Numbers: See Recall Database Entries Manufacturing Dates: June 1, 2017 to April 1, 2022 Distribution Dates:…
How Gene Therapy Can Cure or Treat Diseases
Image Español The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. This…
Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors
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: Abacus Order Entry and Calculation Software Product Codes: See medical device database entry Devices Recalled in the U.S.: 9 (3 versions of software with 3…