The U.S. Food and Drug Administration (FDA) is alerting veterinarians and their customers not to use sterile drug products produced and distributed by a Texas company. The warning regarding I.V. Specialty Ltd., in Austin, is due to sterility concerns after a recent inspection.
The FDA recommended that I.V. Specialty stop producing its sterile products and recall all non-expired sterile drug products. The company has not issued a recall and continues to produce its sterile drug products without making the needed corrections, the FDA states.
The move comes after a recent inspection by the FDA. The agency states investigators found “insanitary” conditions, including poor sterile production practices. There are concerns about I.V. Specialty’s ability to assure the sterility of its veterinary and human drug products.
The FDA recommends veterinarians check their medical supplies and pull any drug products labeled as sterile from I.V. Specialty. The administration of a non-sterile product, intended to be sterile, could result in a serious and potentially life threatening infection or death, the FDA warns.