Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
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
INOVA (benzoyl peroxide)
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class III · Low risk
Endure 400 Scrub-Stat
Subpotent Drug
Class III · Low risk
Protonix I.V.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class III · Low risk
Sodium Ferric Gluconate Complex in Sucrose Injection
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class II · Moderate risk
LEVOXYL (levothyroxine sodium tablets, USP)
Superpotent
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Indiomin MB URINARY ANTISEPTIC
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
AZUPHEN MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
UROPHEN MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
URAMIT MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Urolet Mb Urinary Antiseptic
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Hyolev MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Sodium Chloride Ophthalmic Solution
Subpotent Drug: concentration of product is less than labeled amount.
Class III · Low risk
HCG (Chorionic Gonadotropin Lyopholized)
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Class III · Low risk
Gildess 24 FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1/20
Subpotent Drug; Ethinyl Estradiol
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