AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: FDA 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, Texas. 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. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.
BACKGROUND: In April 2013, 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 inspection. 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.
RECOMMENDATION: For all sterile products from NuVision, the FDA recommends that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision sterile products, quarantine those products, and not administer them to patients. Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178