Clinical Specialties Recalls Products Due to Lack of Sterility

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On March 20, 2013, Clinical Specialties issued a voluntary recall on all lots of all Sterile Products due to lack of sterility assurance.

The recall was conducted following concerns regarding on-site practices which failed to assure the sterility of the products as well as the firms initial recall of Avastin due to reports of eye infections associated to uses of the product. The Center for Disease Control (CDC) has notified the FDA that endophthalmitis infections, occurring inside the eyeball as a result of a contaminated injection, is a serious complication which can even lead to permanent loss of vision.

Compromised sterile products have been shown to put patients are serious risk for infection, leading to possibly fatal conditions. While the Avastin lots have been the only lots with confirmed evidence of contamination, Clinical Specialties has decided that an expanded recall is in the best interest of its patients.

Health care providers have been advised to cease all use of sterile products distributed by Clinical Specialties Compounding until further notice and to return current stock of these products to the company.