FDA Warns New Jersey Compounder About Deficiencies for Making Sterile Drugs

The Food and Drug Administration told Pharmacy Creations in Randolph, N.J., that its investigators found serious deficiencies in the way it produces sterile drugs, according to a warning letter posted July 1 on the FDA’s website.

For example, the agency said its investigators found that the pharmacy produces sterile injectable drugs in multiple-dose containers without a preservative added to the formulations. The FDA said there is a significant risk that the pharmacy’s formulation is unsuitable for multiple uses and will present an increased risk of infection to patients.

The investigators also noted that Pharmacy Creations continues to make domperidone drug ...