Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Gelnique (oxybutynin chloride)
Subpotent Drug: Drug potency was compromised during shipment.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
DermOtic Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class II · Moderate risk
Heparin Sodium Injection
Subpotent; 18 month time point
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Class II · Moderate risk
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Class II · Moderate risk
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Class II · Moderate risk
Clonazepam Tablets
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Class III · Low risk
Ciclopirox Shampoo 1%
Subpotent. drug
Class II · Moderate risk
Fosinopril Sodium and Hydrochlorothiazide Tablets
Subpotent; Hydrochlorothiazide at the 9 month time point.
Class III · Low risk
G & W Fluocinolone Acetonide Cream USP 0.025%
Failed Content Uniformity Specifications; at the 18 month time point.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
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