Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
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
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class III · Low risk
¿Topicort (desoximetasone)
Subpotent Drug
Class III · Low risk
Zemplar (paricalcitol)
Failed Content Uniformity Specifications
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Superpotent Drug: one ingredient was found to be above assay specification.
Class III · Low risk
col-rite (docusate sodium)
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Class III · Low risk
Scrub-Stat 4
Subpotent drug
Class I · High risk
Morphine Sulfate 0.5 mg/mL
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Class III · Low risk
sulfur8 medicated LIGHT FORMULA
Subpotent Drug: failed at the 3 and 6 month stability time points.
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Lindane Lotion
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
Class III · Low risk
Bravelle 75 IU
Subpotent Drug
Class II · Moderate risk
LIPO B STERILE INJECTION 10 mL
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Class II · Moderate risk
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe
Subpotent Drug
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection
Subpotent Drug
Class I · High risk
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection
Subpotent Drug
Class I · High risk
fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection
Subpotent Drug
Class I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
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