Post-re­call, OTC eye drop mak­er hand­ed a warn­ing let­ter from the FDA

In March, Pharmed­ica USA, LLC pulled some of its eye drops off of the shelves over the pos­si­bil­i­ty of the prod­uct not be­ing ster­ile, and its use could re­sult in eye in­fec­tions that cause blind­ness. Now the FDA has re­leased a warn­ing let­ter it sent to Pharmed­ica at the end of last month.

The let­ter said that the FDA in­ves­ti­ga­tor had not­ed that prod­ucts that were sup­posed to be ster­ile were be­ing pre­pared or held in un­san­i­tary con­di­tions, and may have be­come “con­t­a­m­i­nat­ed with filth or ren­dered in­ju­ri­ous to health.” The in­spec­tor al­so not­ed that the fa­cil­i­ty was “in a state of dis­re­pair” and had no ar­eas meant for ster­ile prod­ucts.

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