Schuette and State's Regulatory Chief Suspend License of Texas-based

Pharmacy; Schuette and LARA Advise Michigan Consumers: Do Not

Use Possibly Contaminated NuVision Drugs Marketed as Sterile
Contact: Melanie Brown 517-373-9280
Agency: Licensing and Regulatory Affairs

August 7, 2014 - 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 publics 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 todays 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. Todays action comes
from NuVision Pharmacys 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 Pharmacys license.

Pursuant to state law, Schuettes office filed a Complaint and Order of Summary Suspension on July
31, 2014 with the Department of Licensing and Regulatory Affairs alleging NuVision Pharmacys 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 LARAs Bureau of Health
Care Services director, NuVision Pharmacys 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
theyve 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 Pharmacys 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 Pharmacy products.
More information can be found on the FDA website by viewing the following
link: http://www.fda.gov/Drugs/DrugSafety/ucm405940.htm


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