Clinical Specialties expands on Avastin recall, now includes all sterile products
On the heels of the Avastin unit dose syringe recall earlier this week, Clinical Specialties has announced an expanded recall of All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance, according to an FDA Firm Press Release Wednesday.
The recall notice states:
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. The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process.
Clinical Specialties previously received reports of five endophthalmitis infections due to Avastin from physician’s office and this is how the problem was identified and why the first recall was initiated.
Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013. Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company.
See the list of all the affected products.
Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at [email protected] ; Monday through Friday between the hours of 10 am to 5 pm EST. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.
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