North Carolina has shut down Fayetteville-based Prescription Center Pharmacy and ordered a U.S. and Canadian recall of veterinary products manufactured and distributed by the compounder.
Although no animal illnesses or complaints of injury have yet been reported from any of Prescription Center's products, the agency, along with the FDA, said the compounds under recall lack assurances of "sterility, stability, and potency." The recall order is for products manufactured between Sept. 10, 2014, and March 10 this year.
The products were shipped and distributed to all 50 states and Canada, and are for all lots of nonsterile and sterile products compounded by the company, the state's Board of Pharmacy said. It recommended the products not be used and should be disposed of according to local or state government guidelines.
The FDA has been stepping up its crackdown on compounders and illegal animal and human drug sales.
In February, a 37-count indictment was handed down against the owner and the pharmacist-in-charge of Med Prep Consulting of New Jersey. The two were accused of intentionally defrauding the FDA and the hospitals the company sold to by selling drugs it claimed were prepared in safe conditions when, the government alleges, they cut corners to cut costs.
Last fall, the regulatory agency began to tighten the reins on animal drug compounding by sending three companies warning letters targeted at equine products they allegedly marketed without first getting regulatory approval. Tri-Star Equine, HorsePreRace and Horse Gold all received warning letters from the federal agency accusing them of marketing their compounds in a manner "intended for use in the mitigation, treatment or prevention of disease in animals."
- see the FDA recall notice
- check out the FDA blog