Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance

[Posted 04/02/2015]

AUDIENCE: Health Professional, Pharmacy, Veterinary, Patient

ISSUE: FDA is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina. In an inspection conducted in March by the NC BOP, state inspectors observed significant deficiencies that raise concerns about the company’s ability to assure the sterility, stability and potency of the sterile and non-sterile human and veterinary drug products that it produced. The Prescription Center has been closed by order of the NC BOP, and the NC BOP has ordered a recall of all lots of sterile and non-sterile products compounded or repackaged and distributed by the Prescription Center between Sept. 10, 2014, and March 10, 2015.

BACKGROUND: Drug products made by the Prescription Center have been distributed nationwide and to Canada. Although the FDA is not aware of any adverse events associated with these products, due to concerns about a lack of sterility assurance and other conditions at the facility, and out of an abundance of caution, the FDA and the NC BOP are advising against their use.

RECOMMENDATION: Health care professionals should check their medical supplies, quarantine any drug products from the Prescription Center and should not administer them to either human or animal patients.

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
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 releases, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm441001.htm