Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
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 I · High risk
Lidocaine Hydrochloride
Superpotent Drug
Class III · Low risk
Tydemy
Subpotent Drug
Class II · Moderate risk
Clindamycin and Benzoyl Peroxide Gel
Superpotent Drug
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class I · High risk
Lidocaine Hydrochloride Topical Solution USP 4%
Superpotent Drug
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class III · Low risk
Class III · Low risk
Class III · Low risk
Hydroquinone
Subpotency: one product for active ingredient assay and another one for preservative assay
Class III · Low risk
Sodium Sulfacetamide
Subpotency: one product for active ingredient assay and another one for preservative assay
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug
Class III · Low risk
Donepezil HCL Tablets
Subpotent
Class I · High risk
Lidocaine Hydrochloride Topical Solution
Superpotent Drug
Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodide Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
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