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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.
January 04, 2018 at 8:10 AM
Administration of glass particulate 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.
January 02, 2018 at 2:30 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
January 02, 2018 at 12:00 PM
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
December 26, 2017 at 9:00 AM
Use of a non-sterile injectable product could result in fatal infections in a broad array of patients.
December 26, 2017 at 12:00 AM
AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold.
December 20, 2017 at 6:00 PM
FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
December 20, 2017 at 7:30 AM
Administration of a glass particulate 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.
December 19, 2017 at 3:30 PM
Incorrect placement of electrodes on an infant may result in failure to deliver an effective shock. A delay in therapy could result in serious injury and/or death.
December 19, 2017 at 8:00 AM
Trace amounts of gadolinium may stay in the body long-term.
December 14, 2017 at 8:00 AM
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
December 05, 2017 at 10:00 AM
The use of impacted alcohol prep pads could result in adverse events such as infections.
December 05, 2017 at 7:30 AM
UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
December 01, 2017 at 8:30 AM
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
December 01, 2017 at 8:10 AM
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
November 28, 2017 at 9:00 AM
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.
November 27, 2017 at 10:10 AM
Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.