Class III · Low risk
Oxaydo (oxycodone HCl, USP)
Sub-potent Drug: Lower potency than labeled.
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
Opium Tincture
Subpotent Drug
Class II · Moderate risk
Clinical TREAT Antifungal Powder
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Class III · Low risk
Epinephrine-Lidocaine HCl
Subpotent: Failing Test Results for Epinephrine
Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class II · Moderate risk
Sucralfate Oral Suspension 1g per 10mL
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class II · Moderate risk
Humanrace Suncare
Subpotent Drug: Product does not contain SPF that is declared on the label.
Class II · Moderate risk
Humanrace Suncare
Subpotent Drug: Product does not contain SPF that is declared on the label.
Class III · Low risk
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class III · Low risk
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class III · Low risk
Amlodipine Besylate Tablets
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk
Amphotericin B Liposome for Injection
Subpotent drug
Class II · Moderate risk
Heparin Sodium
Subpotent: Low anti-factor IIa Potency.
Class III · Low risk
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Subpotent Drug: Out of specification results for low potency was obtained.
Class II · Moderate risk
Fast Acting Earwax Removal System
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class III · Low risk
Dodex Injectable Cyanocobalamin Injection
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class II · Moderate risk
Heparin Sodium
Subpotent Drug: low Anti-Factor IIa potency.
Class III · Low risk
Fentanyl 1
Subpotent Drug
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
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