FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483 issued July 16, 2014).Hospira has contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response tracking, returns, effectiveness checks and destruction of product returns.If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product.Brookstone has distributed 344 bottles nationally and has donated 5301bottles to charity for international distribution.To date, Avella has not received any reports of adverse events related to the recall.
Subsequent inspection of retained product by Hospira found additional overfilled Carpuject pre-filled cartridges.Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available.To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump.In the most severe cases, methemoglobinemia can result in death.Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal.All GemStar Infusion Pumps (Models 13000, 13100, 13150, 13086, 13087, 13088) that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia.
Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products would result in an immediate shortage.This can even occur with used patches which still contain a considerable amount of fentanyl.Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.FDA anticipates the receipt of additional data within the next several weeks.Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat rapidly and irregularly.
Products were distributed to customers in the U.S. between June 23, 2014 and October 2, 2014.Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients.Additionally, as part of a broader public awareness campaign about the proper disposal of medications in 2011, FDA advised consumers on the proper disposal of fentanyl patches when they are no longer needed.To date, Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection.If contaminated solution is used on a patient, critical patient harm may result.Therefore, FDA is alerting health care professionals not to use drug products marketed as sterile from Pharmakon.FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant.FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication.
If you have received Wallcur Practi-products by mistake, please contact the distributor, or Wallcur, LLC of San Diego for return instructions.If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips.The revised label includes a new warning about this unapproved use.On April 11, 2016, FDA recommended that Pharmakon cease sterile operations until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile.While these infusion pumps are currently not available for purchase through Hospira, the FDA is aware that the Symbiq Infusion System is potentially available for purchase from third parties not associated with Hospira.The label for the green Night product appears under some of the blue Day product and vice versa.Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention (CDC).If the incorrect barcode on Magnesium Sulfate in Water for Injection is not detected prior to dispensing or administration to a patient, and the product is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the primary container and overwrap are correct.
In April 2013, NuVision recalled Methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.The 2016 investigation also detected B. cepacia in the water system used to manufacture the product.This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy.As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them.Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected.Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product.
FDA will continue to monitor the use of these drugs in children and will update the public if additional information becomes available.
Products: Sutureless Connector Intrathecal Catheters, Models 8709SC, 8731SC Sutureless Revision Kits, Models 8596SC, 8578 Medtronic does not recommend the use of any affected devices with the old design.According to the 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container product labeling, the product should be inspected visually for particulate matter and discoloration whenever solution and container permit.Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions.The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.
The Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems are computerized infusion pumps designed for the continuous delivery of anesthetic or therapeutic drugs.The adverse events occurred when the fentanyl patch was used to treat pain in patients who were not tolerant to opioids and when opioid-tolerant patients applied more patches than prescribed, changed the patch too frequently or exposed the patch to a heat source.If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used.Additionally, unanticipated interactions with other drugs may also lead to serious adverse events.
Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression.This infusion system can communicate with a Hospital Information System (HIS) via a wired or wireless connection over facility network infrastructures.Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older.There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients.All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.See the FDA Class I Recall Notice for a complete list of affected model and lot numbers.Swallowing the gel can result in people receiving dangerously large amounts of the active ingredient diphenhydramine.Compared to its last forecast in September,. but not hitting 2% until 2018.The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.The product will be in the form of an injectable drug or an eye drop.The letters notified customers that Hospira would contact them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test.