Class III · Low risk
Halyard 24-Hour Oral Care Kit q4
Crystallization with subpotent out of specification assay results for chlorhexidine.
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
Halyard 24-Hour Oral Care Kit q2
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Gaviscon (Alumina & Magnesium Trisilicate)
Superpotent Drug: high out-of-specification result for magnesium.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Subpotent Drug: found to be below the specification for labeled assay.
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class III · Low risk
Amoxicillin and Clavulanate Potassium Tablets
Subpotent Drug; Clavulanic Acid
Class III · Low risk
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class II · Moderate risk
EEMT (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk
EEMT HS (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class I · High risk
Hyland's Baby Nighttime Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class I · High risk
Hyland's Baby Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class III · Low risk
Desoximetasone Ointment USP
Superpotent Drug
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class III · Low risk
Fluphenazine Decanoate Injection
Subpotent Drug
Class II · Moderate risk
Cotellic (cobimetinib)
Superpotent Drug: An oversized tablet was found in a bottle.
Class III · Low risk
Dye Free Allergy Softgel Gelatin Capsule
Subpotent
Class III · Low risk
Diphenhydramine HCl 25 mg
Subpotent
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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