Class II · Moderate risk
UVT World Gel Hand Sanitizer 70% Alcohol Content
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 II · Moderate risk
Health & Hand Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
Class II · Moderate risk
Class II · Moderate risk
+Protec Hands Antibacterial Gel Topical Solution Instant…
Subpotent drug
Class II · Moderate risk
Human Chorionic Gonadotropin 1
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 5
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class III · Low risk
Fentanyl
Subpotency: Out-of-specification stability test result for low potency was obtained.
Class III · Low risk
Testosterone Gel 1%
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Class III · Low risk
Clobetasol Propionate Ointment USP 0.05%
Superpotent and Subpotent; low and high assay results
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets
Subpotent
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class I · High risk
NP Thyroid 120
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
NP Thyroid 15
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class III · Low risk
Nymalize (nimodipine)
Subpotent Drug
Class I · High risk
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
WP Thyroid
Subpotent Drug: FDA analysis found product to be subpotent
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
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