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05-24-2013, 10:17 AM #1
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- Aug 2012
- Merced, CA 95348-1422
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NuVision Pharmacy Alert: Lack of Sterility Assurance of ALL Sterile Drug Products
FDA News Release (synopsis)
Consumer Inquiries: 888-INFO-FDA
FDA Expands Alert to Health Care Providers about Lack of Sterility Assurance of all Sterile Drug Products from NuVision Pharmacy
The U. S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, TX. The FDA recommends that these products should not be administered to patients
If a drug marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas Facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company's sterile drug products.
In April, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspections. The FDA received adverse event reports of fever, flu-like symptoms and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled.
Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their healthcare provider.