Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
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
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class III · Low risk
Bucalsep
Subpotent; Cetylpyridinum Chloride
Class II · Moderate risk
Cetacaine Liquid Topical Anesthetic
Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point.
Class III · Low risk
Oxcarbazepine Tablets
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Class III · Low risk
Cherry Cepacol Sore Throat Lozenges
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Class II · Moderate risk
Ethambutol Hydrochloride Tablets
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Class III · Low risk
Acetic Acid Otic Solution
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Class II · Moderate risk
Rifadin
Subpotent drug: low fill volume in some of the capsules
Class II · Moderate risk
Rifadin (rifampin)
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Class III · Low risk
PE Daytime Cold/Flu LiqGel
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Class II · Moderate risk
CLONAZEPAM ORALLY DISINTERGRATING Tablets
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Class II · Moderate risk
ZoDen PD
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
ZoDen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Syrup
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Pediatric Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Tri-Dex PE
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TL-Hist PD Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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