OTC nasal, ear care product manufacturer handed a warning letter

The FDA is­sued a warn­ing let­ter to NeilMed Phar­ma­ceu­ti­cals, an over-the-counter man­u­fac­tur­er of nasal and ear care prod­ucts, cit­ing is­sues with clean­ing and in­gre­di­ent test­ing found at the com­pa­ny’s man­u­fac­tur­ing site dur­ing an in­spec­tion last year.

The agency on Tues­day pub­lished the let­ter, which told the man­u­fac­tur­er that it failed to prop­er­ly test in­com­ing com­po­nents, specif­i­cal­ly glyc­erin, to make sure they do not in­clude di­eth­yl­ene or eth­yl­ene gly­col, known as DEG and EG. Both com­pounds are poi­so­nous. The let­ter, which is dat­ed May 26, states that NeilMed did not per­form “iden­ti­ty test­ing” on each ship­ment of glyc­erin that was used in its prod­ucts.

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