Device & Drug Safety – Presence of Particulate Matter
Not suppliedPublished notice; closure not supplied
Distribution: Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hos...
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
These examples come from this result page and are not a ranking of every recall reason.
Checking Eugia US LLC
Is there a recall on eugia us llc right now?
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