Monday, March 25, 2013

N.J. AG announces second agreement with compounding pharmacy March 25, 2013 12:07 PM By Bryan Cohen

NEWARK, N.J. (Legal Newsline) – New Jersey Attorney General Jeffrey Chiesa announced a second voluntary interim consent order Friday with a Tinton Falls-based compounding center to stop all pharmacy activities pending examination into contaminated products.

The New Jersey State Board of Pharmacy entered into an initial interim voluntary consent order with Med Prep Consulting Inc. on March 15, under which the compounding pharmacy agreed to temporarily stop all pharmacy operations through Friday. The second agreement extends the temporary cessation of all pharmacy activities through April 5.
Through April 5, the New Jersey Division of Consumer Affairs and its Enforcement Bureau will partner with the New Jersey Department of Health, the New Jersey Board of Pharmacy, the U.S. Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration to examine the cause of contamination found in magnesium sulfate products compounded by the company.
“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,” 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.”
Health Commissioner Mary O’Dowd said there were no illnesses connected to the recall.
The staff of a Connecticut hospital identified visible particulate contaminates in bags of magnesium sulfate intravenous solution compounded by Med Prep and sent to the hospital. Med Prep and the FDA announced a voluntary recall of the products on March 16 and an expanded recall of all Med Prep products on March 17.
source found here

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