Class II · Moderate risk
Gasco Isopropyl Alcohol 70%
Subpotent drug
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
Gasco Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Gasco Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class II · Moderate risk
Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class III · Low risk
Magnesium Chloride
Subpotent drug
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Thyroid
Subpotent Drug
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Icosapent Ethyl capsules
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III · Low risk
Klarity-C Drops
Subpotent Drug
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Class II · Moderate risk
Medline
Subpotent Drug
Class I · High risk
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
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