Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
11,818 recalls · Class II, newest first
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
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.
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