Summary Company Announcement Date: April 26, 2023 FDA Publish Date: May 04, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that…
Gear Isle Issues Voluntary Nationwide Recall of Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER Capsules Due to the Presence of Sildenafil and Tadalafil
Summary Company Announcement Date: April 26, 2023 FDA Publish Date: April 26, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil and sildenafil Company Name: Gadget Island, Inc. Brand Name: Brand Name(s) Pro Power Knight Plus, NUX, Dynamite Super Product Description: Product Description Male enhancement capsules Company Announcement…
Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error
Summary Company Announcement Date: April 27, 2023 FDA Publish Date: April 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Safety updates were omitted in the Product Insert/Medication Guide (MG) Company Name: Teva Pharmaceuticals USA Brand Name: Brand Name(s) Mayne Pharma Inc. Product Description: Product Description FENTANYL Buccal Tablets CII Company Announcement 27…
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
April 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service (UCS) software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. These instruments are medical…
Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
Summary Company Announcement Date: April 26, 2023 FDA Publish Date: April 26, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that…
2023 Medical Device Recalls
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment 04/19/2023 Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy 04/07/2023 Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2…
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
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 Product Name: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold; BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold Product Stock Codes: Distribution Dates: October…
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment
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 Product Name: Ivenix Infusion System Model: LVP-0004 Devices Recalled in the U.S.: 1,546 Dates Distributed: October 27, 2021 – January 30, 2023 Date Initiated by Firm: March…
All Opioid Pain Medicines: Drug Safety Communication – FDA Updates Prescribing Information to Provide Additional Guidance for Safe Use
[Posted 04/13/2023] AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy, Caregivers ISSUE: The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. This includes stating for all opioid pain that the risk of overdose increases as the dose increases. The updates to IR opioids state these…
Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
Date Issued: April 12, 2023 The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. The FDA is aware of laboratory test results…