By Elise Viebeck - 10/31/12 07:35 PM EDT
"During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process," the company said.
"Out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations."
Congress, now in recess, has been pushing for answers on the wave of meningitis cases for weeks.
The outbreak has raised questions about compounding pharmacies, firms that reprocess drugs on a large scale to fit patients' needs but are not obligated to follow many rules that apply to drug makers.
Several House Democrats have either introduced or promised legislation that would strengthen federal oversight of drug compounders.