Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class I · High risk Terminated
Levetiracetam Oral Solution 100mg/mL
Reason Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class II · Moderate risk Terminated
Raloxifene Hydrochloride Tablets
Reason Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Amantadine Hydrochloride Tablets
Reason Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Class II · Moderate risk Terminated
25% Dextrose Injection
Reason Labeling: Incorrect or Missing Lot and/or expiration date.
Class II · Moderate risk Terminated
Lidocaine HCl 2% 5 mL
Reason Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Class II · Moderate risk Terminated
Petroleum jelly
Reason Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Class III · Low risk Terminated
VCF Vaginal Contraceptive Foam
Reason Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Vancomycin Hydrochloride for Injection
Reason Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk Terminated
Exparel
Reason Sub Potent Drug: Out of Specification (OOS)
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class III · Low risk Terminated
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Regular Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Nourishing Coconut invisible solid…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class I · High risk Terminated
Mirtazapine Tablets
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I · High risk Terminated
Mirtazapine Tablets
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP 5000 mL bags
Reason Lack of Assurance of Sterility: Product has the potential to leak.