Class II · Moderate risk
SIREtizer Hand Sanitizer
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was 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 II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Pyridostigmine Bromide Oral Solution
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class III · Low risk
ClomiPRAMINE Hydrochloride Capsules
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class III · Low risk
Azacitidine for Injection
Subpotent Drug
Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk
Tegsedi (inotersen)
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Equate Tartar Control Plus
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Class III · Low risk
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic…
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Class I · High risk
Tacrolimus
Subpotent drug
Class I · High risk
Tacrolimus
Subpotent drug
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of Specification results for Assay
Class III · Low risk
Methylprednisolone Tablets
Subpotent
Class III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
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