Unable to Force a Recall, FDA Warns About Drugs Made by Dallas Pharmacy

The FDA has reminded health care providers about the agency’s safety concerns regarding all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. This follows the FDA’s notice on May 18, 2013, initially recommending health care professionals quarantine products from NuVision. NuVision has repeatedly declined to recall its sterile products, and the FDA lacks the authority to demand or force a recall.

In April, NuVision voluntarily recalled methylcobalamin injection and lyophilized injection products due to concerns about sterility. When the FDA inspected NuVision’s facilities, preliminary findings raised questions about sterile production practices and sterility assurance. The FDA issued a letter to NuVision in July 2013, requesting an immediate recall based on poor sterile production practices observed in April of 2013.

NuVision described corrective actions implemented after the inspection; however the FDA responded that the actions do not address the impact of the poor aseptic practices on sterile drugs produced and distributed prior to the implementation of the corrective actions. The FDA also noted that the plan failed to sufficiently address all of the objectionable practices found during the inspection.

NuVision’s website states that it is in compliance with standards of law for compounding pharmacies, and that it will provide results of its third party sterility testing, proving that its products are sterile.