Class II · Moderate risk
Ambi 40pse/400gfn
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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
Ambi 40pse/400gfn/20dm
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 3brm/30dm/50pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 3brm/15dm/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 2cpm/15dm/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25cpd/200gfn
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/120gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/100gfn/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25dph/7.5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 20dm100gfn10peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 15dm/100gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class III · Low risk
Sodium Sulfacetamide 10% and Sulfur 5% Lotion
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Class III · Low risk
Ventavis (iloprost)
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Class III · Low risk
Glycopyrrolate Tablets
Subpotent Drug
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk
Hydrocodone bitartrate and acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class III · Low risk
Clean & Clear advantage
Superpotent (Single Ingredient Drug): salicylic acid
Class III · Low risk
Derma-Smoothe/FS
Subpotent; 22 month stability timepoint
Class III · Low risk
Derma-Smoothe/FS
Subpotent; 12 month stability timepoint
Class II · Moderate risk
Levothyroxine Tablets
Subpotent; 15 month stability (by mfr)
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent; 15 month stability
Class III · Low risk
AcneFree Acne Pore Cleanser
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree Severe Maximum Strength Acne Pore Cleanser
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree 3-in-1 Acne Night Repair Foam
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
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