Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Alert Not to Use Due to Lack of Sterility Assurance
Risk Managers, Pharmacy healthcare personnel and consumers are alerted by the FDA not to use drugs marketed as sterile produced by Downing Labs LLC, aka NuVision Pharmacy, as they may be contaminated.
FDA Alert on Sterile Drug Products by Downing Labs (aka NuVision Pharmacy)
FDA’s reason for the alerts is the Agency’s investigation of NuVision and insanitary conditions that revealed lack of sterility assurance of purportedly sterile drug products. More specifically, there were reported sterility failures in 19 lots of drug products, endotoxin failures in 3 lots, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions including shock, fever, changes in blood pressure, and in other circulatory functions. If a non-sterile drug product is administered, this may cause serious, life-threatening, infections, including death.
FDA Recommendation on Sterile Drug Products by Downing Labs (aka NuVision Pharmacy)
“Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.”
Contacting the FDA to report cases with Sterile Drug Products by Downing Labs (aka NuVision Pharmacy)
In case of detection of adverse events or side effects related to the use of Sterile Drug Products by Downing Labs (aka NuVision Pharmacy), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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