ISSUE: Clinical Specialties is voluntarily recalling all
lots of all sterile products repackaged and distributed by the pharmacy due to
lack of sterility assurance. The recall of all sterile products is conducted in
follow-up to concerns regarding practices at the site which cannot assure the
sterility of the products.
BACKGROUND: This expanded recall follows the firm’s initial
recall of Avastin on March 18, 2013, due to reports of five patients who have
been diagnosed with serious eye infections associated with the use of the
product. The Center for Disease Control and Prevention (CDC) notified the FDA
of these endophthalmitis infections, which occur inside the
eyeball.Endophthalmitis after intravitreal injection is a serious
complication that can lead to permanent loss of vision. Clinical Specialties
Compounding sterile products covered under this recall were distributed
nationwide between October 19, 2012 and March 19, 2013.
RECOMMENDATION: Until further notice, health care providers should
stop using all sterile products distributed by Clinical Specialties Compounding
and return them to the company. Consumers or Health Care providers with
questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915
Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at email@example.com.
Patients who have received any product distributed by Clinical Specialties
Compounding and have concerns should contact their healthcare provider.
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
Read the MedWatch safety
alert, including links to the firm Press Releases, at: http://links.govdelivery.com