Attorney General Bill Schuette and Department of Licensing and Regulatory Affairs (LARA) Acting Director Mike Zimmer today announced the summary suspension of the pharmacy and controlled substance licenses held by Texas-based NuVision Pharmacy, Inc. This order of summary suspension legally prevents NuVision from distributing in Michigan drugs the company has manufactured under less than sterile conditions that may be contaminated. Health care professionals and consumers should immediately stop using any drugs marketed by NuVision Pharmacy. LARA, Bureau of Health Care Services issues an Order of Summary Suspension when it believes that the public’s health, safety, and welfare warrant emergency action.
“Michigan families deserve the highest standards of public health and safety,” said Schuette. “We will continue to aggressively hold every pharmacy providing for Michigan patients responsible for the drugs they distribute. Every pharmacist must put patient safety first.”
“We have zero tolerance for any company distributing medicines in Michigan that may be contaminated due to a history of sterility problems,” said Zimmer. “With today’s license suspension of NuVision Pharmacy, we are determined to avert any possible threat to the health and safety of Michigan citizens.”
The federal Department of Health and Human Services (HHS) conducted inspections of NuVision Pharmacy facilities in Dallas, Texas from June 3, 2014 through July 16, 2014. Today’s action comes from NuVision Pharmacy’s refusal of HHS’ request to immediately recall all lots of sterile products produced at NuVision Pharmacy, and that includes all products entering or distributed in Michigan. LARA obtained a July 16, 2014, report from the Food and Drug Administration (FDA), an HHS agency that documented continued sterility concerns found at NuVision Pharmacy. LARA took immediate action by working in tandem with Schuette to issue an Order of Summary Suspension against NuVision Pharmacy’s license.
Pursuant to state law, Schuette’s office filed a Complaint and Order of Summary Suspension on July 31, 2014 with the Department of Licensing and Regulatory Affairs alleging NuVision Pharmacy’s sale and distribution of drugs in Michigan were marketed as sterile when in fact, they may be contaminated. Once the Order of Summary Suspension was signed by LARA’s Bureau of Health Care Services director, NuVision Pharmacy’s licenses were immediately suspended pending the outcome of the disciplinary process.
On July 19, 2014, the FDA issued a notice to health care professionals and consumers to not use drugs marketed as sterile produced by NuVision Pharmacy due to continued concern with contamination and a lack of sterility assurance. NuVision Pharmacy has refused to recall drugs they’ve manufactured under less than sterile conditions, claiming that they do not qualify as a drug manufacturer, and are not required to follow FDA standards for manufacturing. Between March and April 2013, the FDA found numerous concerns with NuVision Pharmacy’s sterile production practices that raised concerns about a lack of sterility assurance of the sterile products they provide.
To date, there have been no reports of patient illness associated with NuVision products. More information is at: http://www.fda.gov/Drugs/DrugSafety/ucm405940.htm
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