Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns
FOR IMMEDIATE RELEASE - September 6, 2013, San Diego, CA - University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. 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. The preparations would have been sold, directly to customers by pick up and by mail from;
University Compounding Pharmacy 1875 3rd Avenue San Diego CA. 92101. 619) 683-2005
|Product Name||Lot Number||Expiry|
|Testosterone Cypionate (Sesame Oil) 200mg/mL Inj.||511017||11/30/2013|
|Testosterone Cypionate/Testosterone Proprionate 180-20mg/mL Inj||513593||11/30/2013|
|PGE-1 NS 20mcg/mL Inj.||497940||9/6/2013|
|PGE-1 NS 100mcg/mL Inj.||497930||11/5/2013|
|Testosterone CYP (Sesame Oil) 200mg/mL Inj.||498616||9/25/2013|
University Compounding Pharmacy 1765 4th Avenue San Diego CA. 92101. 619) 398-1800
|Testosterone CYP (Sesame Oil) 200mg/mL Inj.||474323||9/13/2013|
|Testosterone CYP (Sesame Oil) 200mg/mL Inj.||475475||9/26/2013|
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.
Adverse reactions 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.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Photo: Product Labels
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.