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, 2013to 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
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
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 HERE.
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 11/16/2013)