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FDA Warnings

Latest FDA Updates

Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance

Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use

UPDATED 06/23/2017. All unexpired lots of the RX, OTW, and CS versions are recalled. Material in the patient's bloodstream can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

Patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code

Risk of failure of the device to initiate therapy.

Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance

There is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

A patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017

Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure

Failed dissolution could result in less drug being absorbed. Posted 06/15/2017

Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency

An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient’s conditions. Posted 06/15/2017

Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors

Accuracy errors may lead to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures Posted 06/15/2017

Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices

The possibility of decreased quality and consistency of the product, may have an impact on the safety and efficacy of the product posing a risk to patients.


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