AUG 14, 2013
Cataract/Anterior Segment, Comprehensive Ophthalmology, Cornea/External Disease, Glaucoma, Neuro-Ophthalmology/Orbit, Ocular Pathology/Oncology, Oculoplastics/Orbit, Pediatric Ophth/Strabismus, Refractive Mgmt/Intervention, Retina/Vitreous, Uveitis
The FDA has announced a voluntary nationwide recall of all sterile use products produced and distributed by a Texas compounding pharmacy, Specialty Compounding in Cedar Park, Texas. The pharmacy is responding to reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions. However, the pharmacy also supplies sterile products to ophthalmologists and ophthalmic ambulatory surgery centers.
Facilities, health care providers and patients who have received any sterile product since May 9, 2013 should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding.
According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.
The FDA has received reports of 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in sodium chloride 0.9 percent for injection, supplied by Specialty Compounding. The patients developed bacterial bloodstream infections caused by Rhodococcus equi. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding showed growth of bacteria that are consistent with Rhodococcus species.
“The FDA believes that use of these products would create an unacceptable risk for patients," said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. "Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
The FDA is working closely with the Centers for Disease Control and Prevention and Texas state officials to determine the scope of the contamination.
Adverse reactions experienced with the use of any Specialty Compounding products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: https://www.accessdata.fda.gov/scripts/medwatch/
• Download form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1-800-332-1088 to request a reporting form, then complete and mail to address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.