Clinical Specialties Compounding Pharmacy Recalls All Sterile Products
March 21, 2013
Clinical Specialties Compounding Pharmacy is voluntarily expanding a recall of Avastin (bevacizumab) unit dose syringes to include all lots of all sterile products repackaged and distributed by the company due to concerns of possible contamination. The company initially recalled Avastin (bevacizumab) unit-dose syringes after receiving five reports of intraocular infection from a physician’s office where the product was used. No evidence of contamination has been found with any sterile products other than the Avastin syringes. However, the sterility of the products packaged at Clinical Specialties Compounding Pharmacy is being questioned due to some unspecified practices at the facility.
Recalled sterile products were distributed throughout the United States between October 19, 2012 and March 19, 2013. A list of recalled products is available at: http://www.fda.gov/Safety/Recalls/ucm344786.htm. Affected Avastin products were distributed to doctors in Georgia, Indiana, Louisiana, and South Carolina between December 18, 2012 and March 18, 2013. This recall does not affect FDA-approved presentations of Avastin (Genentech), labeled for treating cancer.
Clinical Specialties has contacted providers who received Avastin products affected by this recall. Doctors should immediately stop using all sterile products distributed by Clinical Specialties. Questions can be directed to Clinical Specialties (phone: 866-880-1915 or email: email@example.com). Patients who experience problems that may be associated with any recalled product are encouraged to contact their healthcare providers.
FDA encourages consumers and healthcare professionals to report adverse reactions to FDA’s MedWatch Program at www.fda.gov/medwatch.
- March 21, 2013:
- March 18, 2103:
Press Release & Product List:
- Sterile Products Recall (3/20/13):
March 21, 2013; March 20, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.