Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
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
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Cephalexin for Oral Suspension
Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk
Buprenorphine HCl Injection
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk
UltraCruz Hand Sanitizing Gel Antimicrobial
Subpotent drug
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent drug: Out of specification for assay at the 15-month test interval.
Class II · Moderate risk
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class III · Low risk
Clobetasol Propionate Cream
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class I · High risk
STIMATE (desmopressin acetate)
Superpotent Drug
Class I · High risk
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Superpotent Drug
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