Summary Company Announcement Date: September 03, 2020 FDA Publish Date: September 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is labeled as edible alcohol. Company Name: CorgioMed LLC Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand…
RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency
Summary Company Announcement Date: September 03, 2020 FDA Publish Date: September 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may be sub potent Company Name: RLC Labs, Inc Brand Name: Brand Name(s) Product Description: Product Description Nature-Throid® and WP Thyroid® Company Announcement RLC Labs, Inc. is voluntarily recalling a total of…
Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is reminding health care providers of the importance of conducting a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS). As part of the its ongoing monitoring of the safety and effectiveness of medical devices, including the review of published…
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…
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…
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…