The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy1 (CSCP) of Augusta, Ga. after preliminary findings raised concerns about a lack of sterility assurance, including reports of five patients who have been diagnosed with serious eye infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.
The Centers for Disease Control and Prevention notified the FDA of these infections, called endophthalmitis, which occurs inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. CSCP repackaged the Avastin into individual single-use syringes from manufactured vials labeled as sterile.
CSCP’s sterile products covered under this expanded recall were distributed nationwide between Oct. 19, 2012, and March 19, 2013. Until further notice, health care providers should stop using all sterile products distributed by CSCP and return them to the company.
“A compromised sterile product puts patients at risk for serious infections,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “Health care professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered.”
The FDA continues to work with the CDC and state health departments to determine the scope of any contamination.
Patients who have received any product distributed by CSCP and have concerns should contact their health care provider. The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch3 program by going online to www.fda.gov/medwatch/report.htm Forms can also be submitted via fax at 1-800-FDA-0178
Health care providers with questions may contact CSCP at 866-880-1915, Monday through Friday, between 10 a.m. and 5 p.m. eastern time.
This is the second recall of all sterile drug products in the last three days. On March 18th the FDA announced by a voluntary nationwide recall of all sterile products produced by Med Prep Consulting Inc. of Tinton Falls, N.J. That recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.
The magnesium sulfate products may have been distributed to additional facilities in Connecticut, New Jersey, and Pennsylvania. Until further notice, health care providers should stop using all products made by Med Prep Consulting Inc. and return them to the company.
“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients.”
This investigation is ongoing. The FDA is working with the Centers for Disease Control and Prevention and state officials in New Jersey and Connecticut to determine the scope of the contamination. The level of recall is to the user level, this includes regional hospital pharmacies and related departments, and physician’s office practices. This recall includes all products distributed through March 15, 2013.
In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.