Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
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
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Loratadine Orally Disintegrating Tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class II · Moderate risk
Ortho-Cept
Subpotent Drug
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk
Flurandrenolide Tape
Subpotent Drug: Flurandrenolide is subpotent.
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Rose Bengal GloStrips
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class II · Moderate risk
Vancomycin Hydrochloride Capsules
Subpotent Drug
Class II · Moderate risk
Vancomycin Hydrochloride Capsules
Subpotent Drug
Class III · Low risk
Nicardipine Hydrochloride Injection
Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class III · Low risk
5-methyltetrahydrofolate Calcium
Subpotent Drug
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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