FDAOctober 18, 2018drug

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

What to do

FDA enforcement status: Terminated

Brands named

h j harkins company inc dba pharma pac

UPCs

1747802831052959010300

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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