Sagent Pharmaceuticals Pulls Blood Pressure Drug Over Sterility Snag
Sagent Pharmaceuticals has recalled three lots of its phenylephrine hydrochloride injection, manufactured by partner Indoco Remedies, because of sterility concerns.
The product in question had a possibly loose vial seal that could result in the drug becoming nonsterile, the FDA said, adding that a nonsterile product could lead to a life-threatening infection.
The drug is an alpha-1 adrenergic receptor agonist used to treat low blood pressure caused by blood vessel dilation during the administration of anesthesia. Sagent has not received any adverse event reports to date, the agency said.