Class III · Low risk Terminated
CTx7 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Labeling: Missing Label
Class III · Low risk Terminated
Morphine Sulfate Oral Solution 100 mg per 5 mL
Reason Labeling: Missing Label
Class III · Low risk Terminated
Telmisartan and Hydrochlorothiazide Tablets
Reason Superpotent; Hydrochlorothiazide
Class III · Low risk Terminated
Tydemy
Reason Subpotent Drug
Class III · Low risk Terminated
Carvedilol Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy Relief D Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy Relief D Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
12 HR Allergy & Congestion Relief Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class III · Low risk Terminated
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy & Congestion Relief Allergy Relief D
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Reason Failed dissolution specifications
Class III · Low risk Terminated
Clonidine Transdermal System
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Topiramate Tablets
Reason Discoloration
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Film Coated Tablets
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Xpect First aid Extra Strength PAIN AWAY
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Advance Formula Pain Reliever
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.