Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
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.
Failed Content Uniformity Specifications
Superpotent drug
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Subpotent drug
Subpotent drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Sub-Potent Drug: Subpotent assay results during stability testing.
Sub-Potent Drug: Subpotent assay results during stability testing.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
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