Class I · High risk
AMPD GOLD Bee Pollen capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
iNDiGO capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Class I · High risk
EDGE Amplified Weight Release capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class III · Low risk
Nicardipine Hydrochloride Injection
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class II · Moderate risk
Levetiracetam
Failed Dissolution Specifications: 6 month time point.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: One lot exceeded the mechanical peel specification
Class III · Low risk
5-methyltetrahydrofolate Calcium
Subpotent Drug
Class I · High risk
Practi-0.9% Sodium Chloride
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Class II · Moderate risk
Glycopyrrolate injection
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Class II · Moderate risk
Virazole (Ribavirin for Inhalation Solution, USP)
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk
Total parenteral nutrition various strengths
Lack of sterility assurance.
Class II · Moderate risk
L-cysteine various strengths
Lack of sterility assurance.
Class II · Moderate risk
Immune globulin g human various strengths
Lack of sterility assurance.
Class II · Moderate risk
Diphenhydramine 50 mg/ml vials
Lack of sterility assurance.
Class II · Moderate risk
Dehydrated alcohol vials
Lack of sterility assurance.