Safety Alert on Pharm D Solutions Products

FDA is alerting health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston, TX) due to lack of sterility assurance. FDA says it sent the firm a Warning Letter 12/2016, and a recent follow-up inspection in August cited insanitary conditions, including poor sterile production practices and deficient environmental monitoring. “These conditions raised concerns about the company’s ability to assure the sterility of its drug products,” it says in a Web posting.

In September, the posting says, Pharm D recalled all unexpired drug products intended to be sterile and agreed to cease sterile operations until it makes adequate corrections at its facility. However, the firm resumed sterile operations in October and distributed products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on 11/9, but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile.