Date Issued: April 5, 2022 The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies (also known as 522 studies). Given the cleaning concerns and…
UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
April 4, 2022 As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being changed updated by Karl Storz. The…
Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene
Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol in Mickey Mouse and Presence of Benzene in The Mandalorian Company Name: Best Brands Consumer Products, Inc. Brand Name: Brand Name(s) Mickey Mouse, The Mandalorian Product Description: Product Description Hand…
F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared Sildenafil
Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: F&S Medical Supply, dba Pink Toyz Brand Name: Brand Name(s) F&S Medical Supply, dba Pink Toyz Product Description: Product Description Pink Pussycat Capsules Company Announcement FOR IMMEDIATE RELEASE –…
Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene
Summary Company Announcement Date: March 30, 2022 FDA Publish Date: March 30, 2022 Product Type: CosmeticsDrugs Deodorant Reason for Announcement: Recall Reason Description Elevated levels of benzene Company Name: Unilever Brand Name: Brand Name(s) Product Description: Product Description Aerosol Antiperspirants Company Announcement March 30, 2022 – Englewood Cliffs, New Jersey– Unilever United States is voluntarily…
Iodine-Containing Contrast Media: Drug Safety Communication – FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging
[Posted 03/30/2022] AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. These…
Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: March 29, 2022 FDA Publish Date: March 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Particulate Matter (silica and iron oxide) Company Name: Teva Pharmaceuticals Brand Name: Brand Name(s) Teva Pharmaceuticals Product Description: Product Description IDArubicin Hydrochloride Injection USP Company Announcement Teva Pharmaceuticals has initiated a voluntary…
Prefilled Saline Flush Syringe Conservation Strategies – Letter to Health Care Personnel
March 21, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency,…
Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect
Summary Company Announcement Date: March 21, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential clogging of the needle preventing the dispensing of epinephrine Company Name: Adamis Pharmaceuticals Corporation Brand Name: Brand Name(s) Adamis Pharmaceuticals Corporation Product Description: Product Description SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3…
Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content
Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, N-nitroso-quinapril Company Name: Pfizer Brand Name: Brand Name(s) Accuretic, Greenstone Brand Product Description: Product Description Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets Company Announcement NEW YORK,…