Drug Alert: Lack of Sterility Assurance

The FDA has issued a formal request to Downing Labs for an immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of drug products made at the Downing Labs facility.

FDA investigators inspected the firm’s NuVision facility in Dallas, Texas in July, and observed insanitary conditions that result in a lack of sterility assurance that puts patients at risk. The inspection revealed sterility failures in 19 lots of drug products intended to be sterile; endotoxin failures in three lots of drug products; and inadequate or no investigation of these failures. NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

Risk: Endotoxins, which are substances found in certain bacteria, cause a wide variety of serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Recommendations

• Consumers who have received any drug product produced by NuVision and have concerns should contact their healthcare professional.