Tirosint - Sol
Subpotent Drug
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Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Subpotent Drug: Low assay result observed during long-term stability testing.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Short Fill
Short Fill: Underfilled units.
CGMP Deviations: potential for trace amounts of product carryover.