Recall -- Firm Press Release
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Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two
Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance
FOR IMMEDIATE RELEASE - August 23, 2013, Irvine, Ca. Park Pharmacy & Compounding Center is voluntarily recalling two lots of products Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the 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.
The prescription preparations were sold during June and July of 2013, in the following states: California, Florida, New Mexico 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).
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. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. We are voluntarily recalling the products as a precautionary measure for the safety of our patients.
Park Pharmacy & Compounding Center 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 Park Compounding to arrange for return of unused product.
Customers with questions regarding this recall can contact Park Pharmacy & Compounding Center at 949-551-7195 or at firstname.lastname@example.org. 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.
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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.