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Medicine Recalls

The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants. 5/26/2023 12:28:00 PM

SD BioSensor is recalling some Pilot COVID-19 At-Home Tests for the risk that a bacteria contamination could harm users or cause false test results. 5/25/2023

Draeger Seattle PAP Plus and some breathing circuit or anesthesia kits may have parts that loosen or detach, preventing needed breathing support. 5/24/2023

Replacement batteries for ICU Medical's Plum 360, Plum A+ and Plum A+3 large volume infusion pumps may have shorter than expected battery life. 5/22/2023

San Juan, PR, Novis PR LLC esta retirando voluntariamente el lote D20911 Exp 10/25 de gotas pediatricas G-Supress DX a nivel de consumidor. Se ha encontrado que algunas cajas del producto contienen un producto incorrecto en su interior. El producto incorrecto en el interior es un... 5/19/2023

San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR... 5/19/2023

Renuvion/J-Plasma device can be used for additional aesthetic skin procedures 5/10/2023

SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected tests can be identified by the lot number on... 5/5/2023

Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by... 5/4/2023

UV wands may cause injury to the skin, eyes, or both after a few seconds of use. 5/4/2023

Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test. 5/4/2023

Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various... 5/4/2023

Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne's label. This recall has been... 4/28/2023

Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results. 4/27/2023

West Sacramento, CA, Gear Isle is voluntarily recalling the following products listed in the table below to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as Phosphodiesterase Inhibitors (PDE-5)... 4/26/2023

A cracked manifold on some BALLARD ACCESS Closed Suction Systems may cause inadequate ventilation or other injury to vulnerable patients. 4/21/2023

Fluid leaking into the Ivenix Infusion System may prevent the pump from delivering fluid or stop working before therapy is finished. 4/19/2023

FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. The FDA is adding a new warning about opioid-induced hyperalgesia. 4/13/2023

Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations. 4/12/2023

Certain Philips Respironics DreamStation CPAP and BiPAP Machines are recalled because they may not deliver the right correct amount of breathing support. 4/7/2023

The readers that are part of FreeStyle Libre Glucose Monitoring Systems may grow extremely hot or catch on fire, posing significant risk to users. 4/6/2023

Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader's... 4/3/2023

Communication loss between Executive Processor and Video Generator PCBAs may cause unexpected shutdown, interrupting therapy to the patient with no warning. 3/31/2023

Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. : In the population most at risk, immunocompromised population, there is a reasonable... 3/31/2023

Certain dental devices have not been cleared or approved by the FDA. 3/30/2023

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