Summary Company Announcement Date: March 27, 2024 FDA Publish Date: March 27, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent due to bottles being overfilled Company Name: Amneal Pharmaceuticals, LLC. Brand Name: Brand Name(s) Product Description: Product Description Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL Company Announcement FOR IMMEDIATE RELEASE…
Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Due to Presence of White Particles
Summary Company Announcement Date: March 28, 2024 FDA Publish Date: March 28, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Presence of Particulate Matter Company Name: Eugia US LLC Brand Name: Brand Name(s) Eugia US LLC Product Description: Product Description Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single…
Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist
Please be aware, this recall is a correction, not a product removal. 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 Names: Medline Kits and Trays Distribution Dates: November 1, 2021 to November 10, 2023…
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Date Issued: March 19, 2024 The U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the FDA is taking to address these issues. In November 2023, the FDA informed consumers, health care…
Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System
Summary Company Announcement Date: March 20, 2024 FDA Publish Date: March 20, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems Company Name: InfuTronix, LLC Brand Name: Brand Name(s) Product Description: Product Description Nimbus Pump System…
Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death
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 Names and Codes: AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, 2K8000 AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, without Mask, 2K8001 …
Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks
Please be aware, this recall is a correction, not a product removal. 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 US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with…
Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis)
Summary Company Announcement Date: March 19, 2024 FDA Publish Date: March 20, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil Company Name: Pyramid Wholesale Brand Name: Brand Name(s) Product Description: Product Description Dietary supplements for sexual enhancement Company Announcement FOR IMMEDIATE RELEASE – March 19, 2024, Los Angeles,…
Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants
Summary Company Announcement Date: March 01, 2024 FDA Publish Date: March 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential interference with certain medical implants Company Name: Sleepnet Corporation Brand Name: Brand Name(s) Mojo, Mojo 2, iQ 2, Phantom 2 Product Description: Product Description CPAP and BIPAP Masks with Magnets Company…
Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
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 Device Use Avanos Medical MIC Gastric-Jejunal Feeding Tube and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors are designed for patients who require simultaneous gastric decompression and jejunal…