Class II · Moderate risk
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
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
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Latanoprost P-F
Subpotent Drug
Class III · Low risk
Nystatin and Triamcinolone Acetonide Cream USP100
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class II · Moderate risk
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk
Heparin Sodium 25
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Class III · Low risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Subpotent Drug.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Etomidate Injection
Subpotent Drug.
Class III · Low risk
Oxytocin 30 Units added to NS 500 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 20 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 10 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
0.9% Buffered Lidocaine HCl
Subpotent
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
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