State Board of Pharmacy, Med Prep Enter Voluntary Agreement, Extending Halt to Pharmacy's Operations Following Recall
View Second Voluntary Consent Order
View Voluntary Consent Order
NEWARK – The New Jersey State Board of Pharmacy today announced a Second Voluntary Interim Consent Order with Med Prep Consulting Inc., a compounding pharmacy in Tinton Falls, to further extend the temporary cessation of all of Med Prep's pharmacy activities pending further examination into the cause of contamination found in magnesium sulfate products compounded by the company.
The Board of Pharmacy on Friday, March 15, entered into an initial Interim Voluntary Consent Order with Med Prep, under which the business agreed to temporarily halt all pharmacy operations until at least today. (View 3/15/13 Press Release)
Under the terms of today's agreement, Med Prep has agreed to remain closed until at least April 5, while the State Division of Consumer Affairs and its Enforcement Bureau, in partnership with the State Department of Health, State Board of Pharmacy, U.S. Food and Drug Administration, and U.S. Centers for Disease Control and Prevention, continue to investigate the root cause of the contamination found in the Med Prep products.
"This agreement between the Board of Pharmacy and Med Prep ensures the company will remain closed, while we continue to investigate the root cause of the contamination that was discovered in certain Med Prep products last week," Attorney General Jeffrey S. Chiesa said. "The State Division of Consumer Affairs and its Enforcement Bureau, on behalf of the State Board of Pharmacy, continue to investigate this matter in partnership with the State Department of Health, U.S. Food and Drug Administration, and Centers for Disease Control and Prevention."
"There are no reported illnesses associated with this recall at this time," said Health Commissioner Mary E. O'Dowd. "The Department is working closely on this ongoing investigation with affected health care facilities in New Jersey and with the CDC, the FDA, Connecticut, Pennsylvania and the state Board of Pharmacy."
Neither today's Consent Order nor the initial Consent Order is a disciplinary action, and does not represent an admission of wrongdoing by Med Prep.
This action results from the identification of visible particulate contaminants, by the staff of a Connecticut hospital, in bags of magnesium sulfate intravenous solution that had been compounded by Med Prep and dispensed to the hospital. As of this date, no injuries or illnesses have been reported.
Med Prep and the FDA on March 16 publicly announced a voluntary recall of bags of magnesium sulfate intravenous solution compounded by Med Prep. The recall notice can be found at http://www.fda.gov/Safety/Recalls/ucm344189.htm. On March 17, Med Prep and the FDA publicly announced an expanded recall of all lots of all Med Prep compounded products. A revised version of that recall notice, issued on March 20, can be found at http://www.fda.gov/Safety/Recalls/ucm344787.htm.
Deputy Attorneys General Kim Ringler and Jodi Krugman, of the New Jersey Division of Law, are representing the State in this matter.
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