FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS

IS THIS THE NEW “POSTER CHILD” FOR NON-COMPLIANCE?

On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacy”.  The FDA indicated that the rationale behind the News Release was because the products’ sterility could not be assured.  The Alert follow the FDA’s notice on May 18, 2013 recommending that health care providers and other health care professionals immediately check their medical supplies for this Company’s sterile products, quarantine those products and not administer them to patients.

NuVision Pharmacy has repeatedly declined to recall its sterile products. The FDA most recently issued a letter to NuVision on July 26, 2013, requesting an immediate recall of all lots of sterile products 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 explained that those practices raised concerns about a lack of sterility assurance of NuVision’s sterile drug products.  The FDA noted that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections.

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.

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’s April 2013 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.  The agency is not aware of any adverse event reports associated with other sterile products from NuVision.

When a Company decides to “flaunt” the FDA regarding a Recall and choose to ignore the request, they may have won the battle, but not the war.   Perhaps NuVision had not reviewed the FDA’s rules regarding potential issues for not “voluntarily” recalling product that the FDA believed should be recalled.   Below are listed several of the highlights from the FDA’s recall requirements, “Guidance for Industry: Product Recalls, Including Removals and Corrections”.

Sec. 7.40   Recall policy (a) Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration.  Recall is a voluntary action that takes   place because manufacturers and distributors carry out their responsibility   to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  This section and 7.41 through 7.59 recognize the voluntary nature of recall by providing guidance so that responsible firms may effectively discharge their recall responsibilities.  These sections also recognize that recall is  an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products by setting forth specific recall procedures for the Food and Drug Administration to monitor recalls and assess the adequacy of a firm’s efforts in recall. (b) Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration.  A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled. (c) Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed.  Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.