The U.S. Food and Drug Administration (FDA) is informing patients and healthcare providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is aware of the potential for overdose if the user does not clear the moat area around the tip of the ENFit

Medtronic updated this recall with information that Medtronic will replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty

Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection. This recall is due to a lack of sterility assurance resulting from compounding in a newly installed biologic safety

The U.S. Food and Drug Administration (FDA) issued revised guidance to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including healthcare personnel, and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for healthcare personnel for the duration of the COVID-19 public health emergency: Enforcement Policy for Face Masks,

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to

Letter to Healthcare Providers The U.S. Food and Drug Administration (FDA) is alerting healthcare facility risk managers, procurement staff, and healthcare personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH)

The U.S. Food and Drug Administration (FDA) has granted full approval of the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available

Aug. 12, 2021 | The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered

SterRx, LLC announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL,

Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion. Ingesting hand sanitizer, which is intended for