NEW YORK (AP) -- The FDA on Sunday announced a recall of all products produced and distributed for sterile use by Specialty Compounding LLC because of concerns about bacterial infections
The Cedar Park, Texas, company is recalling all lots of its unexpired sterile compounded medications sold since May 9, including all strengths and dosage forms.
The company announced the recall late Friday.
The agency said the recall follows reports of bacterial infections affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. All of the cases involved treatment that included IV infusions of calcium gluconate from Specialty Compounding.
There is a potential association between the infections and the medication, the notice states. It adds that if there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
The company said the recalled products were sent directly to patients nationwide, with the exception of North Carolina. They were also distributed directly to hospitals and physician offices in Texas.
Specialty Compounding, a subsidiary of Peoples Pharmacy Inc., is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the products to Specialty Compounding.
More details are available by calling Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. Central time.
Consumers should contact a health care provider if they have experienced any problems that may be related to taking these drug products. Reactions can also be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.
Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors. The industry has come under scrutiny in recent months after a fungal meningitis outbreak traced to tainted steroids produced at the now-shuttered New England Compounding Pharmacy in Framingham, Mass., killed 61 people and sickened more than 700 others.