FDA NEWS RELEASE
For Immediate Release: March 21, 2013
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy
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 Pharmacy (CSCP) of Augusta, Ga. The recall of all sterile products is due to the FDA’s preliminary findings of practices at the site which raise concerns about a lack of sterility assurance. This expanded recall comes after reports of five patients who have been diagnosed with serious eye infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it 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.
Lucentis (ranibizumab injection) and Eylea (aflibercept) are approved by the FDA for the treatment of wet age-related macular degeneration. Avastin is not approved by the FDA for this purpose. Avastin is approved for other indications.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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