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MedPrep Product Recall

by admin on March 19, 2013

WASHINGTON — The Food and Drug Administration warned doctors and hospital managers Monday about a nationwide recall of all drugs made by a New Jersey compounding pharmacy because of possible mold contamination.

The recalled products from Med Prep Consulting Inc. include dozens of antibiotics, pain relievers and drugs used in surgery and labor. The drugs were packaged in infusion bags, plastic syringes and glass vials and distributed to regional hospitals in Delaware, New Jersey, Pennsylvania and Connecticut.

Tinton Falls, N.J.-based Med Prep said Saturday that mold was found in five bags of magnesium sulfate dispensed to a Connecticut hospital. Magnesium sulfate is used to control seizures and premature labor in pregnant women.

Med Prep is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors’ specifications. The recall marks the second time in less than a year that a compounding pharmacy has recalled all of its products because of contamination.

A tainted steroid distributed last year by a Massachusetts-based compounding pharmacy killed 50 people and has sickened more than 720 nationwide. Many of the cases involved a rare form of meningitis tied to fungus found in the New England Compounding Center’s facilities. The company has been shut down since the outbreak was discovered in September.

In recent weeks the FDA has stepped up inspections of compounding pharmacies across a dozen states.

No injuries have been reported to date from Med Prep products, but the FDA says it is working with officials in New Jersey and Connecticut to determine the scope of contamination.

“We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients,” Janet Woodcock, director of the FDA’s drug center, said in a statement.

The New Jersey State Board of Pharmacy reached an agreement with the company on Friday to shut down all production and shipping of medications.

Med Prep produces liquid drug formulations that given to patients intravenously.

Syndicated from Delaware Online

 

Toyota Brake Light Recall Attorneys DE

by admin on February 11, 2013

DETROIT (AP) — U.S. safety regulators are looking at expanding a small recall of Pontiac G6 midsize cars so it includes up to 550,000 vehicles.

About 8,000 of the cars were recalled by General Motors in 2009 because the brake lights and cruise control were defective.

But the recall affected only cars made in January of 2005. On Friday, the U.S. National Highway Traffic Safety Administration said in documents posted on its website that it’s studying whether all G-6s from the 2005 through 2009 model years should be added to the recall.

The safety agency says it has received 212 complaints from consumers that brake lights won’t come on when the pedal is pressed, or the lights come on for no reason. Some of the complaints also say the cruise control disengages for no reason, or it may not work at all.

No crashes or injuries have been reported from the problem, and GM says it is cooperating with the investigation.

In the 2009 recall, GM traced the problem to corrosion in a wiring connector. Dealers were to fix it by putting a lubricant on the connector to prevent corrosion.

But NHTSA said Friday that complaints persisted from people with G6s from additional model years, so it will look at an expanded recall.

In one complaint from December of 2012, the owner of a 2007 G6 told NHTSA of problems with brake lights and the cruise control.

“I have been having issues with my brake lights coming on while I am accelerating, and the brake lights go off when I brake, putting me at higher risk for an accident,” the owner wrote.

NHTSA does not identify people who file complaints, and in most cases, does not reveal where they live.

Owners who suspect brake light or cruise control problems should take their cars to any Chevrolet, Buick, Cadillac or GMC dealer. GM shut down the Pontiac brand in 2010 as part of its massive restructuring.

Although the Chevrolet Malibu and Saturn Aura share many components with the G6, they are not included in the probe, GM spokesman Alan Adler said.

http://hosted2.ap.org/RIPRJ/365856ab22144091bcb2622414c99806/Article_2013-02-08-General%20Motors-Brake%20Lights/id-babb177db6ba4007957a4a11f6f27497

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