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Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance
AUDIENCE: Health Professional, Risk Manager
ISSUE: 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.
BACKGROUND: The prescription preparations were sold during June and July of 2013, in 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).
RECOMMENDATION: Customers with questions regarding this recall can contact Park Pharmacy & Compounding Center at 949-551-7195 or at info@xxxxxxxxxx. 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. 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.
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
Read the complete MedWatch Safety Alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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