FDA announces voluntary recall of several medicines containing valsartan following detection of an impurityMonday, July 16, 2018
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”Read More
Rising Numbers of Deaths Involving Fentanyl and Fentanyl Analogs, Including Carfentanil, and Increased Usage and Mixing with Non-opioidsWednesday, July 11, 2018
This Health Alert Network (HAN) Update is to alert public health departments, health care professionals, first responders, and medical examiners and coroners to important new developments in the evolving opioid overdose epidemic, which increasingly involves illicitly manufactured fentanyl and an array of potent fentanyl analogs (i.e., compounds that are chemically related to fentanyl). It is the second update to the original health advisory, HAN 384, issued October 26, 2015, which alerted the public to the increase in unintentional overdose fatalities involving fentanyl in multiple states, primarily driven by illicitly manufactured fentanyl. The first update to this health advisory was released on August 25, 2016 (HAN 395), describing the sharp increase in the availability of counterfeit pills containing varying amounts of fentanyl and fentanyl analogs, the continued increase of overdose deaths involving fentanyl across a growing number of states, and the widening array of fentanyl analogs being mixed with heroin or sold as heroin.
The current update includes information on: (1) the continued increase in the supply of fentanyl and fentanyl analogs detected by law enforcement; (2) the sharp rise in overdose deaths involving fentanyl and fentanyl analogs in a growing number of states, in particular the growing number of deaths involving the ultra-high potency fentanyl analog known as carfentanil; (3) the expanding number of poly-drug combinations implicated in opioid overdose deaths, which include non-opioids, such as cocaine; (4) the updated comprehensive guidance available to law enforcement and other emergency responders to prevent occupational exposure to fentanyl and fentanyl analogs; and (5) updated recommendations for public health professionals and health care providers regarding prevention and response efforts.Read More
Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side EffectsWednesday, July 11, 2018
Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems.
Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug.Read More
Outbreak of Hepatitis A Virus (HAV) Infections among Persons Who Use Drugs and Persons Experiencing HomelessnessTuesday, June 12, 2018
The Centers for Disease Control and Prevention (CDC) and state health departments are investigating hepatitis A outbreaks in multiple states among persons reporting drug use and/or homelessness and their contacts. This Health Alert Network (HAN) Advisory alerts public health departments, healthcare facilities, and programs providing services to affected populations about these outbreaks of hepatitis A infections and provides guidance to assist in identifying and preventing new infections.Read More
Class 2 Device Recall Liberty Select CyclerFriday, June 8, 2018
Fresenius Technical Service identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
On 01/25/2018, the recalling firm sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk.
On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning.
Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times.
The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.com.Read More
Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride InjectionFriday, June 8, 2018
Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.
In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.
Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.Read More
The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.
Update – CDC Recommendations for Managing and Reporting Shigella Infections with Possible Reduced Susceptibility to CiprofloxacinFriday, June 8, 2018
This Health Alert Network (HAN) Update provides current recommendations on management and reporting of Shigella infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN 401: CDC Recommendations for Diagnosing and Managing Shigella Strains with Possible Reduced Susceptibility to Ciprofloxacin.
The Centers for Disease Control and Prevention (CDC) continues to identify an increasing number of Shigella isolates that test within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (minimum inhibitory concentration [MIC] values of 0.12-1 μg/mL), but harbor one or more resistance mechanisms. CDC remains concerned about potential clinical failures with fluoroquinolone treatment.
Clinicians should carefully monitor patients with Shigella infections who require fluoroquinolone treatment and report any possible treatment failures. If treatment failure is suspected, clinicians should submit a stool specimen for antimicrobial susceptibility testing, and consider consulting an infectious disease specialist to identify best treatment options.Read More
HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the ControllerTuesday, June 5, 2018
Medtronic is recalling the HeartWare HVAD because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption to the electrical connection, which occurs when the power source is still physically connected, is caused by oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death.
A full list of affected devices is available in the FDA recalls database.Read More
HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft OcclusionWednesday, May 23, 2018
The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.
- Recalled Products: HeartMate 3™ Left Ventricular Assist System
- Model/Item Numbers: Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international)
- Lot Numbers: All lots
- Manufacturing Dates: All
- Distribution Dates: September 2, 2014 to present
- Devices Recalled in the U.S.: 4,878 units nationwide
Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate MatterThursday, May 10, 2018
AuroMedics Pharma is voluntarily recalling two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level.
The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.Read More