Saturday, March 16, 2013

Voluntary recall of medical products from Tinton Falls pharmaceutical company

By Tomas Dinges/The Star-Ledger 
on March 16, 2013 at 12:32 AM, updated March 16, 2013 at 1:05 AM


The state is recommending medical products from a Monmouth County company be taken off the shelves and production halted after concerns that bags of intravenous fluid may be contaminated, officials said.
Bags of magnesium sulfate solution produced by Tinton Falls-based Med Prep
Consulting
 shipped to a Connecticut hospital may have been contaminated with visible floating particles, according to a release late Friday night by state Attorney General Jeffrey Chiesa and Health Commissioner Mary E. Dowd.
The recall also includes magnesium sulfate products that “may have been dispensed to additional facilities elsewhere, including New Jersey and Pennsylvania,” according to the statement released late last night.
As a precautionary measure, any health care facility that has received products from the company should remove them from use, said O’Dowd.
It is unclear how many other medical facilities received the products made by Med Prep.
Officials confirmed bags of the solution were sent to the Yale New Haven Hospital in New Haven.
As of Friday, the company entered into a voluntary consent order with the state until at least March 22 and agreed to halt all operations, including the production and shipment of medications, officials said.
"The State Board of Pharmacy and Med Prep have agreed that the pharmacy will stop producing and shipping medications until additional information about the potentially contaminated products can be gathered and analyzed,” Chiesa said.
State agencies are monitoring the situation along with the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention and Connecticut’s department of health.
Studies have shown that magnesium sulfate taken intravenously can reduce the incidence of cerebral palsy in babies when infused into their pregnant mothers, and also act as an anticonvulsant and replenisher of electrolytes to prevent seizures in pregnant women, according to the National Institutes of Health.
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