FDA Warning Targets NuVision Sterile Products

Posted on August 20, 2013

This past April, the Dallas, Texas-based NuVision Pharmacy announced a recall of lyophilized injections and methylcobalamin injections due to worries that the sterility of the items may have been compromised.  At the time, there had been reports of soreness, fever, and side effects not all that different from what one would experience with the flu.  Following a Food and Drug Administration inspection at the Dallas plant, the recall was issued.

But that wan’t the end of the story.  In May, the FDA warned all healthcare providers to cease giving any sterile products from NuVision to patients.  Their inspection had turned up practices that were not conducive to sterility, and the organization was worried that the continued distribution and administration of the injections could imperil the safety of patients.

Since that time, the FDA has sought to compel NuVision to announce a recall of the products, but that has not come to fruition at this time.  The most recent request from the FDA came in the form of a letter issued last July relating to NuVision the FDA’s worry that compromised sterility could lead to a product contamination that could severely injure or even kill a patient.

NuVision has decided not to comply.  Thus, the FDA has issued a new alert once again asking healthcare professionals to cease providing the drugs and to quarantine them.  Patients previously given the injections and who present symptoms should seek immediate medical care.

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