April 2, 2015
The U.S. Food and Drug Administration’s Center for Veterinary Medicine is urging veterinarians and pet owners 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 North Carolina Board of Pharmacy (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.
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. Veterinarians should check their medical supplies, quarantine any drug products from the Prescription Center and should not administer or prescribe them to their patients. Pet owners should check their pet’s medications for products from the Prescription Center, safely dispose of them, and consult their prescribing veterinarian for alternative medications.
Veterinarians or pet owners who note adverse reactions or quality problems with the use of these products may report them to the FDA’s MedWatch Adverse Event Reporting program:
- Submit FORM FDA 1932a (download PDF), which is a pre-addressed, prepaid postage form that can be completed or dropped in the mail; or
- Call the Center for Veterinary Medicine: 1-888-FDA-VETS. Leave your name, address, phone number, and the brand name of the drug involved. Ask to have a Form FDA 1932a sent to you.
Veterinarians and pet owners may also report adverse events to the NC BOP:
- Online at firstname.lastname@example.org
- Via fax at 919-246-1056
The FDA will continue to work closely with the NC BOP to protect the public health.