FDA: Don't Use Any Sterile Product From NuVision Pharmacy

Megan Brooks

Disclosures

August 16, 2013

In a statement issued today, the US Food and Drug Administration (FDA) reminds healthcare providers not to use any sterile products made by compounding pharmacy NuVision Pharmacy.

There continue to be "safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. Health care providers should not administer any NuVision Pharmacy sterile products to patients because the products' sterility is not assured," the FDA said.

"NuVision Pharmacy has repeatedly declined to recall its sterile products," the FDA said today. In a letter to NuVision dated July 26, 2013, the agency requested an immediate recall of all lots of sterile products produced at NuVision that have not passed their expiration dates.

In the letter, the FDA outlined poor sterile production practices observed by FDA investigators during an April 2013 inspection of NuVision's Dallas facility. The FDA said those practices raised concerns about the lack of sterility assurance of NuVision's sterile drug products.

If a drug product marketed as sterile contains microbial contamination, "patients could be at risk for serious, potentially life-threatening infections," the FDA said.

NuVision responded to the letter by refusing to recall its sterile products.

"Under its authority, the FDA cannot require NuVision to undertake such a recall. Therefore the agency reminds health care providers not to use any sterile products from NuVision," the FDA said today.

In April, as reported by Medscape Medical News , NuVision recalled methylcobalamin injection and lyophilized injection products because of lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

The FDA said today that it has received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the recalled methylcobalamin injection product.

On May 18, the FDA advised healthcare providers not to use any sterile product from NuVision Pharmacy because of concerns about a lack of sterility assurance, as reported by Medscape Medical News .

To report problems with these products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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