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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