Class II · Moderate risk
PDI Povidone-Iodine Swabstick
SubPotent: Out of Specification
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
PDI Povidine Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad Large
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad MEDIUM
SubPotent: Out of Specification
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class III · Low risk
B-Force
Superpotent
Class II · Moderate risk
QiYu Hand Sanitizer Gel
Subpotent
Class III · Low risk
Readyprep Chg
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 120 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 90 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 60 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 30 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 15 Thyroid Tablets
Subpotent Drug
Class II · Moderate risk
Cefixime for Oral Suspension USP 100 mg/5mL
Subpotent Drug
Class III · Low risk
Dry Eye Test
Subpotent Drug
Class II · Moderate risk
Cefprozil for Oral Suspension USP
Superpotent Drug
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent
Class II · Moderate risk
Lidocaine/Tetracaine
Superpotent Drug. Lidocaine higher concentration than listed
Class II · Moderate risk
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
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