BD Provides Update on Previously Disclosed Recall of BD Alaris System Hardware

Summary Company Announcement Date: August 20, 2020 FDA Publish Date: September 01, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Hardware issues may cause the infusion pump to not operate as expected Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) Product Description: Product Description Alaris Infusion Pump Company Announcement Majority…

The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil

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…

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,…

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…

Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

Summary Company Announcement Date: August 25, 2020 FDA Publish Date: August 25, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol (wood alcohol) and subpotent ethanol levels Company Name: Asiaticon SA de CV Brand Name: Brand Name(s) V-Klean, Medical Minded, Protz Product Description: Product Description Hand Sanitizer Company Announcement Mexico…