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Recalls for Shirley drug maker

Four of the American Regent pharmaceutical products subject

Four of the American Regent pharmaceutical products subject to recent FDA recalls. Photo Credit: FDA Flickr photostream

A pharmaceutical drug maker based in Shirley has recalled nine of its products in recent months due to foreign particles -- such as glass or a "rust colored" substance --found in vials that had already been shipped for patient use, a federal safety agency said.

The nine voluntary recalls, by American Regent Inc., made up 26 percent of all drug recalls in the United States since December.

Methyldopate HCL Injection, USP is used to treat hypertension, the FDA notice said. The product was distributed to wholesalers and distributors nationwide.

No injuries or deaths related to the recalls were reported by the Food and Drug Administration. American Regent did not immediately respond to a request for comment Tuesday.

The most recent recall was June 6, for single-dose, 5 milliliter vials of methyldopate HCL for injection.

The prescription products included sterile water; caffeine and sodium benzoate; ammonium molybdate; dexamethasone sodium phosphate; bacteriostatic sodium chloride; potassium phosphates and sodium bicarbonate. Many of the substances were contained in single-dose or multi-dose vials for injection.

The FDA says it oversees or orders the recall of a substance because it is either "defective or potentially harmful." Sometimes a company discovers a problem and recalls a product on its own, the FDA said.

"Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation," the FDA said.


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