Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Thyroid Medication Recalls
Recalls of levothyroxine and other thyroid hormone replacement drugs, often over sub-potency.
226 recalls in this category, newest first.
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Thyroid powder
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid Powder
Reason CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid Powder USP
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid Powder USP
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid Powder 25kg/drum
Reason CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class II · Moderate risk Terminated
Liothyronine Sodium USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Levothyroxine Sodium USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Liothyronine SR
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent
Class II · Moderate risk Terminated
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Reason Superpotent Drug and Subpotent Drug; potency failures obtained
Class II · Moderate risk Terminated
All thyroid Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All T4-levothyroxine Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All methimazole Products
Reason Lack of Processing Controls
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