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Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance
AUDIENCE: Health Professional
ISSUE: Nature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the consumer level. The product will be in the form of an injectable drug or an eye drop. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
BACKGROUND: This recall is being conducted as a result of an inspection conducted by the North Carolina Board of Pharmacy. These products were supplied to the offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area in North Carolina. They were distributed from January 1, 2013 to present. Out of abundance of caution and in the interest of the pharmacy's patients, Nature's Pharmacy has decided to voluntarily proceed with this recall process and to cease production of all sterile products.
RECOMMENDATION: Medical professionals, clinics, or patients who have these products should stop its use and return them to the place of purchase. Clinics should contact any patient that has received treatment using any of these sterile products. Consumers or health care providers with questions regarding this recall may contact Nature's Pharmacy at 828-251-0094 or toll free at 800-645-8201 Monday through Friday, 9:30 am to 6:00 pm EST or by e-mail: naturespharmacy@xxxxxxxxxxxx.
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 MedWatch Safety Alert, including links to the Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm375412.htm
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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