Recall report: Sagent Pharma pulls low blood pressure med for loose sealing on sterile vials
Sagent Pharmaceuticals has recalled three lots of its phenylephrine hydrochloride injection after a customer complaint noted “potentially loose crimped vial seals” that could affect the product’s sterility, the FDA said last week.
A non-sterile sterile injectable is — obviously — a major safety concern, and the FDA warned that a “breach in sterility assurance in distributed product, while remote, cannot be eliminated.”
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