The FDA's preliminary findings at the company's Augusta, Ga., facility “raise concerns about a lack of sterility assurance,” the agency said in the recall alert.
The recall comes amid heightened scrutiny of compounding pharmacies, many of which have morphed into large-scale operations shipping mixed and repackaged pharmaceuticals across the country unregulated by the FDA. The agency's reach is limited to drug manufacturers.
Last fall, a national outbreak of fungal meningitis was traced to steroid injections tainted by shoddy practices at the New England Compounding Center.
As a result, state agencies are bolstering their oversight of compounding, and federal lawmakers are working to give the FDA clear authority to regulate certain types of compounders. The FDA, meanwhile, has been paying surprise visits to compounding pharmacies.
Earlier this week, the FDA warned doctors and hospitals that Med Prep Consulting, Tinton Falls, N.J., was recalling dozens of antibiotics, pain relievers and drugs used in surgery and labor.
The company said the recall was issued because of possible mold contamination of the drugs, which were packaged in infusion bags, plastic syringes and glass vials and distributed to regional hospitals in New Jersey, Pennsylvania, Connecticut and Delaware.