FDA MedWatch Safety Alerts
Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack
Risk of sub-therapeutic dose as well as potential microbial contamination.
Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.
NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter
Administration to a patient may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage
Risk of serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
Administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown
Ventilator shutdown may cause serious adverse health consequences, including death.
Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
Reports of hair loss, hair breakage, balding, itching, and rash.
Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results
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.
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