Class II · Moderate risk
Nystatin Oral Suspension
SubPotent Drug: Low out-of-specification results for assay testing.
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
Buprenorphine Black Cherry 2 mg Troche
Subpotent Drug
Class II · Moderate risk
Buprenorphine Watermelon 8 mg Troche
Subpotent Drug
Class II · Moderate risk
Buprexone Banana cream 6-0.6 mg Troche
Subpotent Drug
Class II · Moderate risk
Levonorgestrel and Ethinyl Estradiol Tablets USP
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class III · Low risk
Bekyree
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class II · Moderate risk
Peppermint Lip Moisturizer
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class II · Moderate risk
Class III · Low risk
PCA Skin Blemish Control Bar
Superpotent Drug: Salicylic acid content is above the firm's specification.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class III · Low risk
Class III · Low risk
Class III · Low risk
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class II · Moderate risk
Exparel
Sub Potent Drug: Out of Specification (OOS)
Class III · Low risk
Motion Sickness Strips
Subpotent Drug
Class III · Low risk
Wal-Dram 2
Subpotent Drug
Class III · Low risk
Motion Sickness
Subpotent Drug
Class III · Low risk
Zentrip (meclizine Hydrochloride)
Subpotent Drug
Class III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk
Pioglitazone Hydrochloride Tablets USP 15 mg
Superpotent
Class II · Moderate risk
Dextroamphetamine Sacharate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class III · Low risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
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