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8/10 - Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Posted By Administration, Saturday, August 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.

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

Refer to the Firm Press Release for additional details.

Read the MedWatch Alert, including a link to the FDA Press Release HERE.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 8/10/2013)

Tags:  FDA  Patient Safety  Recall 

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