Summary Company Announcement Date: September 01, 2020 FDA Publish Date: September 01, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared sildenafil Company Name: The Protein Shoppe, LLC Brand Name: Brand Name(s) Product Description: Product Description Red-E male enhancement tablet Company Announcement The Protein Shoppe, LLC is voluntarily recalling all lots…
Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol
Summary Company Announcement Date: August 29, 2020 FDA Publish Date: August 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Products labeled to contain methanol Company Name: Open Book Extracts Brand Name: Brand Name(s) Always Be Clean, Just Product Description: Product Description Hand Sanitizer Company Announcement Open Book Extracts (OBX) is voluntarily recalling…
Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol
Summary Company Announcement Date: August 14, 2020 FDA Publish Date: August 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1 propanol Company Name: HARMONIC NATURE S. DE R.L. Mi Brand Name: Brand Name(s) Harmonic Nature Product Description: Product Description Hand sanitizer Company Announcement Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily…
Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care providers that gowns sold as medical gowns, including surgical gowns, sold by Laws of Motion PPE (LawsofMotionPPE.com) have potential quality issues that affect the level of fluid barrier protection. The FDA is recommending that gowns manufactured…
TreeHouse Foods Announces Voluntary Recall of Certain Signature Select Granola Bars
Summary Company Announcement Date: August 28, 2020 FDA Publish Date: August 28, 2020 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: TreeHouse Foods, Inc. Brand Name: Brand Name(s) Signature Select Product Description: Product Description Chewy Granola Bars – Chocolate Chip Company Announcement TreeHouse Foods,…
Mammography: What You Need to Know
Español Mammograms continue to be the best primary tool for breast cancer screening. The U.S. Food and Drug Administration (FDA), along with some FDA-approved state agencies, certify facilities to perform mammography; and the FDA clears and approves new mammography devices for sale in the U.S. Congress enacted the Mammography Quality Standards Act (MQSA) in 1992…
Birmingham Man Indicted on Conspiracy and Fraud Charges for Making Unapproved Drug Products in His Kitchen and Warehouse and Marketing and Selling Them as a Cancer Treatment
Department of JusticeU.S. Attorney’s OfficeNorthern District of Alabama FOR IMMEDIATE RELEASEWednesday, August 26, 2020 BIRMINGHAM, Ala. – A twenty-eight-count indictment filed today in U.S. District Court charges a Birmingham man with conspiracy and other fraud charges related to his purchase, manufacture, and distribution of drug products that had never been reviewed or approved by the FDA, but…
Nanomateriales, SA de CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol
Summary Company Announcement Date: August 26, 2020 FDA Publish Date: August 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1-propanol. Company Name: Nanomateriales, SA de CV Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL,…
What To Know If Your Child Wants Contact Lenses
Image These days, eyeglasses can look pretty cool. Still, the day may come when your child asks you for contact lenses. There are pros to consider — and cons. The U.S. Food and Drug Administration regulates contact lenses and certain contact lens care products as medical devices. Contact lenses have benefits. They can be better…
Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert – Boxed Warning about Risk of Leg and Foot Amputations Removed
[Posted 08/26/2020] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: Based on FDA’s review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) was removed from the prescribing information. FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which…