Recall -- Firm Press Release
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Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance
William B. Cheek
FOR IMMEDIATE RELEASE - November 13, 2013, Asheville, NC, - Nature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling of 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. In the event a sterile product is compromised patients are at risk for very serious infections. Therefore, 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. 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.
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.
Nature's Pharmacy is notifying its customers by fax, phone or e-mail to return products to the pharmacy. 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: email@example.com.
Be advised, this recall does not pertain to any non-sterile compounded medications produced by the pharmacy. Patients who have received any product by Nature's Pharmacy and have concerns should contact their healthcare provider.
Adverse reactions or quality problems experienced with the use of any of the recalled drugs 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 3500 available
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.