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February 23, 2018 at 3:00 PM
Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
February 22, 2018 at 9:40 AM
Prescribers advised to consider using other antibiotics in patients with heart disease.
February 13, 2018 at 5:00 PM
Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated.
February 09, 2018 at 11:00 AM
Continued use of the device in AED mode after failure may lead to serious patient injury or death.
February 07, 2018 at 11:00 AM
Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.
February 05, 2018 at 7:00 PM
FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.
February 02, 2018 at 8:30 AM
Probability of a potentially sight threatening eye infection or impairment.
February 01, 2018 at 12:10 PM
FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
January 31, 2018 at 8:00 AM
Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.
January 30, 2018 at 9:00 AM
Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.
January 30, 2018 at 8:40 AM
UPDATED 01/30/2018. Primus voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level.
January 24, 2018 at 9:00 AM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
January 24, 2018 at 9:00 AM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
January 23, 2018 at 9:20 AM
UPDATED 01/23/2018. Recall expanded to include a second lot (NC109123). Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
January 22, 2018 at 12:00 AM
Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018
January 22, 2018 at 12:00 AM
Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018
January 18, 2018 at 2:00 PM
Use of a non-sterile injectable product could result in fatal infections.
January 17, 2018 at 9:40 AM
Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.
January 16, 2018 at 10:40 AM
Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
January 12, 2018 at 4:20 PM
CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.
January 12, 2018 at 1:30 PM
General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.
January 11, 2018 at 11:30 AM
An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
January 11, 2018 at 9:00 AM
Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death.
January 11, 2018 at 8:00 AM
Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
January 10, 2018 at 7:00 PM
Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.