Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Thyroid Medication Recalls
Recalls of levothyroxine and other thyroid hormone replacement drugs, often over sub-potency.
235 recalls in this category, newest first.
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothyroxine Sodium 325mcg/Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
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