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…
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error
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 Medfusion Syringe Pumps Model 3500, firmware version 6.0.0Models 3500-0600-00, -01, -249, -51, -82 Model 4000, firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0Models 4000-0105-249, -50, -51, -78, 4000-0106-00,…
SCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationwide Recall of Heparin Sodium Compounded Products Due to Incorrect Preservative (Benzyl Alcohol)
Summary Company Announcement Date: August 18, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect preservative (benzyl alcohol) Company Name: SCA Pharmaceuticals Brand Name: Brand Name(s) SCA Pharma Product Description: Product Description Heparin Sodium Compounded products Company Announcement Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10…
Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Due to Potential Presence of Undeclared Methanol
Summary Company Announcement Date: July 31, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Methanol Company Name: ALBEK de Mexico S.A. de C.V. Brand Name: Brand Name(s) Nuuxsan, Modesa, more Product Description: Product Description Hand Sanitizer Company Announcement SAN JUAN del RIO QUERETARO, Mexico — ALBEK…
Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: August 19, 2020 FDA Publish Date: August 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Bayshore Pharmaceuticals, LLS Brand Name: Brand Name(s) Bayshore Pharmaceuticals, LLS Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750…
Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers – Letter to Health Care Providers
Dear Health Care Provider and Health Care Facility, The U.S. Food and Drug Administration (FDA) is alerting health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have Coronavirus Disease 2019 (COVID-19) may pose an increased…
Grupo Asimex De Mexico Sa De CV Issues Voluntary Nationwide Recall of All Lots of Florence Morris Antiseptic Hand Sanitizer Due to Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol
Summary Company Announcement Date: August 17, 2020 FDA Publish Date: August 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company Name: Grupo Asimex de Mexico SA de CV Brand Name: Brand Name(s) FLORANCE MORRIS Product Description: Product Description Antiseptic Hand Sanitizer, 70% Alcohol Company Announcement Grupo Asimex de Mexico…
Maison Terre Issues Voluntary Nationwide Recall of Organic Goldenseal Root Powder Due to Microbial Contamination
Summary Company Announcement Date: August 17, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination Company Name: Maison Terre Brand Name: Brand Name(s) Maison Terre Product Description: Product Description Goldenseal Root Powder Company Announcement North Little Rock, AR, Maison Terre is voluntarily recalling all…
Grupo Yacana México S.A.S De C.V. Issues Voluntary Nationwide Recall of All Lots of Yacana Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol
Summary Company Announcement Date: August 18, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol Company Name: Grupo Yacana México S.A.S de C.V. Brand Name: Brand Name(s) Product Description: Product Description Yacana Hand Sanitizer, 70% Alcohol Company Announcement Guadalupe,…
Risk of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software. The test is a molecular assay for the…