Class III · Low risk
Rodan & Fields Proactiv Solution
Subpotent Drug: Salicylic acid is subpotent.
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
Rodan & Fields Proactiv Solution
Subpotent Drug: Salicylic acid is subpotent.
Class I · High risk
Morphine Sulfate Injection
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Class III · Low risk
Magnesium Sulfate in Water for Injection
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Class III · Low risk
DermaZinc Spray
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Class III · Low risk
Balnetar Therapeutic Tar Bath
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Class II · Moderate risk
Thyro-Tab.075 mg.
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 6-month test interval.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class II · Moderate risk
Thyro-Tab 0.050mg.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Class II · Moderate risk
Leflunomide tablets
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class II · Moderate risk
Leflunomide tablets
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
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