Class III · Low risk
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Wrong potency or content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.
992 FDA drug recalls with this cause, newest first.
These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.
Class III · Low risk
Advanced Protection Sunscreen spf 30
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class II · Moderate risk
Monsel's (Ferric Subsulfate)
Superpotent Drug: contains higher levels of Iron than labeled.
Class III · Low risk
Absorica (Isotretinoin)
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Superpotent Drug.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class III · Low risk
Amlodipine Besylate USP 10 mg Tablets
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class II · Moderate risk
Lidocaine 1% + Epinephrine 1:100
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class I · High risk
Norepinephrine 4 mg
Subpotent Drug: Product may not have the active ingredient present in the bag.
Class I · High risk
Levothyroxine and Liothyronine
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
Levothyroxine and Liothyronine
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
Levothyroxine and Liothyronine
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
Levothyroxine and Liothyronine
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
Levothyroxine and Liothyronine
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 III · Low risk
Acne Treatment Pads
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class II · Moderate risk
CVS Health
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class III · Low risk
Cicatricure
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class III · Low risk
Well at Walgreens
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class II · Moderate risk
Premier Value
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk
FREEZE IT (camphor 0.2% and menthol 3.5%)
Superpotent Drug: high out of specification assay results for the camphor ingredient.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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