Home > FDA Issues UPDATED Alert: Recall of All Clinical Specialties Compounding Pharmacy Products—Including Avastin Unit Dose Syringes; Lack of Sterility Assurance
On March 21, the FDA issued an updated alert for an expanded recall of all lots of ALL sterile products repackaged and distributed by Clinical Specialties due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site that cannot assure the sterility of the products.
Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915, Monday through Friday, 10 am to 5 pm EST, or by email at email@example.com.
On March 18, Clinical Specialties voluntarily recalled its Avastin unit dose syringes. The product has resulted in or potentially could result in an infection within the eye. Clinical Specialties received reports of endophthalmitis infections from physicians’ offices. This product was being used solely in an off-label use by ophthalmologists for macular degeneration and is packaged in sterile syringes distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana between October 19, 2012 and March 19, 2013. This product would be administered by a licensed physician in a surgery or physician’s office setting. For the list of product lot numbers click HERE.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.