Safety Alerts

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Reason for Recall Fresenius Kabi is recalling a certain lot of the Ivenix LVP Primary Administration Sets afterRead More »

The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The disruption in supply of this device is expected to impact patient diagnosis, follow-up patient management, and antimicrobial stewardship efforts. The FDA recommends laboratories andRead More »

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. Device Use The Fresenius Medical Care Sanxin Single Use Sterile Syringes are used during hemodialysis treatments. They are used to draw heparin, a blood thinning medicine used to prevent blood clots.Read More »

The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands. On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medicalRead More »

Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the link below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples. Risk Statement Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreignRead More »

CDC recently released a new Resources to Prepare for Flu, COVID-19, and RSVwebpage which provides toolkits and resources for various communities on preparing for the flu, COVID-19, and respiratory syncytial virus (RSV) during the fall/winter season.Read More »

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. The devices described in this recall are related to the ongoing evaluation announced in the Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured byRead More »

Hospira, Inc., a Pfizer company, is voluntarily recalling lots of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter. There isRead More »

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted. Sandimmune® Oral Solution (cyclosporine oral solution,Read More »

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to notify clinicians and caregivers about increases in respiratory syncytial virus (RSV) activity across some parts of the Southeastern United States in recent weeks, suggesting a continued shift toward seasonal RSV trends observed prior to the COVID-19 pandemic.Read More »

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDARead More »

Issue The U.S. Food & Drug Administration (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 products should not be used forRead More »

The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers, the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) whenRead More »

Today, the U.S. Food and Drug Administration (FDA) added a new case study to its “Examples of Medical Device Misconnections” webpage. The webpage describes device misconnections based on reports of adverse events received by the FDA and includes tips to reduce these types of events from occurring. The new case study involves an air inflationRead More »

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. Device Use CADD ambulatory infusion systems deliver controlled amounts of medications to patients in hospital, outpatient, and home settings. The CADD Administration Sets and CADD Medication Cassette Reservoirs areRead More »

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. Most patients reported using artificial tears. Patients reported more than 10 different brands of artificialRead More »

Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters are implanted and used in hemodialysis (treatment to filter waste and water from the blood), apheresis (a technology that separates donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream) for up to 21 days. Medtronic is recallingRead More »

The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). FDA’s review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, orRead More »

Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level. The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports ofRead More »

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: COVID-19 Ag Rapid Test Device Product Codes: See Recall Database Entry Distribution Dates: July 23, 2021 to January 23, 2022 Devices Recalled in the U.S.: 110,000Read More »

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certainRead More »

The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testingRead More »

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.  Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a sampling swab and a tube containing viral sampling medium (the liquid that maintains a specimenRead More »

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. The Palindrome and Mahurkar catheters are implanted and used in hemodialysis (treatment to filter waste and water from your blood), apheresis (a technology that separates donated blood components toRead More »

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalledRead More »

The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Read MoreRead More »

The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still beRead More »

Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion canRead More »

Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed ofRead More »

B. Braun Medical Inc. (B. Braun) is voluntarily recalling five lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers. The biggest risk with a slow leak inRead More »

The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA.Read More »

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling five lots of Lidocaine HCl Topical Solution 4% because the firm’s testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. Use of the super potent product would result in a higher than intended lidocaineRead More »

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 ENFitRead More »

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 warrantyRead More »

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 safetyRead More »

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,Read More »

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 toRead More »

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)Read More »

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 availableRead More »

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 consideredRead More »

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,Read More »

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 forRead More »

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six U.S. cases of a rare type of blood clot in individuals after receiving the J&J COVID-19 vaccine that were reported to the Vaccine Adverse Event Reporting System (VAERS). In these cases, a type ofRead More »

Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug labelRead More »

The U.S. Food and Drug Administration (FDA) authorized revised fact sheets for healthcare providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the treatment of COVID-19. FDA is providing this information to equip healthcare providers with theRead More »

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age andRead More »

The U.S. Food and Drug Administration (FDA) is alerting patients and healthcare providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment; lack of monitoring of infected individuals and their household or otherRead More »

Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) at the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in theRead More »

Two different mRNA vaccines have now shown remarkable effectiveness of about 95 percent in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDARead More »

The purpose of this Health Alert Network (HAN) Advisory is to alert public health departments, healthcare professionals, first responders, harm reduction organizations, laboratories, and medical examiners and coroners to— substantial increases in drug overdose deaths across the United States, primarily driven by rapid increases in overdose deaths involving synthetic opioids excluding methadone (hereafter referred toRead More »