San Diego, California pharmacy, University Compounding Pharmacy, announced the voluntary recall of several injectable preparations over concerns of sterility of the products.
Testosterone Cypionate (Sesame Oil)
Image/FDA
Image/FDA
The Food and Drug Administration (FDA) says investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory testresults. FDA has concerns thatresults obtained from the laboratory are not reliable.
The FDA notes if there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
However, the FDA says, to date there have been NO reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. We are voluntarily recalling the products as a precautionary measure for the safety of our patients.
The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013.
University Compounding Pharmacy is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers that have product which is being recalled should stop using it and contact University Compounding Pharmacy to arrange for return of unused product.
Customers with questions regarding this recall can contact University Compounding Pharmacy at 1875 Third Ave, San Diego CA 92101 619-683-2005. Monday through Friday, 8 A.M. to 6 P.M, Pacific Standard time. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these preparations.
No comments:
Post a Comment