BETHESDA, MD 16 April 2013—Dallas-based ApothéCure Inc. and NuVision Pharmacy are recalling some of their compounded sterile preparations because of concerns about sterility assurance, according to company press releases circulated this morning by FDA.
The press release from NuVision states that FDA had inspected the pharmacy and identified "concerns associated with the quality control processes."
Both pharmacies occupy suites in the same building and compound "Sterile, Risk Level HIGH" and nonsterile preparations, according to the Texas State Board of Pharmacy's database.
NuVision's recall pertains solely to unexpired lots of lyophilized "HcG 5000IU" and "Sermorelin/GHRH6" in 5-mL vials.
ApothéCure is recalling all lots of its unexpired sterile products.
Both pharmacies said they supplied the products to medical professionals' offices.
The causes of the Dallas pharmacies' recalls—lack of sterility assurance and concerns about quality control processes—were the same as the ones for Green Valley Drugs' recall earlier this month.
Scot Silber, president of Green Valley Drugs in Henderson, Nevada, said FDA had requested the recall after surveying the pharmacy against the federal regulations on good manufacturing practice, or GMP, for finished pharmaceuticals.
He said the inspectors observed "procedures that are not acceptable for 211 standards," referring to the part of the Code of Federal Regulations that specifies GMPs.
"The difficulty here," Silber said, "is that they're holding us to higher" standards than United States Pharmacopeia chapter 797, "Pharmaceutical Compounding—Sterile Preparations."
Regulators should first establish the "playing field" and then hold players to its rules, he said.