FDA MedWatch - Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections - Update

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: FDA MedWatch - Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections - Update
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections - Update

[Update 08/10/2013] Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time.

Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina.

Refer to the Firm Press Release for additional details.

Read the MedWatch Alert, including a link to the FDA Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm364595.htm


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux