Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance

[Posted 09/10/2013]

AUDIENCE: Consumer, Pharmacy, Patient, Health Professional

ISSUE:  Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level. In a recent inspection, FDA investigators observed that methods used by Front Range Laboratories 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.

BACKGROUND: The prescription preparations were sold during May and June of 2013, in the following states: California and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).

RECOMMENDATION:  Customers that have product which is being recalled should stop using it and contact Park Compounding to arrange for return of unused product.

Customers with questions regarding this recall can contact Park Compounding Center at 949-551-7195 or at info@parkrx.com. Monday through Friday, 9am to 5pm PST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these preparations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/10/2013 - Firm Press Release - FDA]