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FDA MEDWATCH ALERTS

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

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FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

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FDA Medwatch Alert 10-20-14

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Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination

Monday, February 10, 2014

AUDIENCE: Health Professional, Risk Manager, Patient

ISSUE: FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations’ calcium gluconate injection product. The testing identified gram-positive rod bacteria in the product. A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection.

BACKGROUND: Rx Formulations recalled products marketed as sterile on December 13, 2013.

RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, and quarantine the affected products.

Patients who were administered any drug marketed as sterile produced by Rx Formulations between Nov. 7 and Dec. 11, 2013, and who have concerns, should contact their health care provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Statement, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm

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