Class III · Low risk
Gildess 1/20
Subpotent Drug; Ethinyl Estradiol
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
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Estradiol 12.5 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 200 mg/Anastrazole 20mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Estradiol 3 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone 12.5 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 60 mg/Anastrazole 4 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone Cholesterol
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 200 mg/Anastrozole 9 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Superpotent Drug and Subpotent Drug; potency failures obtained
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class II · Moderate risk
Trokendi XR
Superpotent Drug: Failure of assay specifications in the capsule.
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class III · Low risk
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE…
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
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