Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Antacid Liquid Regular Strength Antacid & Anti-Gas
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Class II · Moderate risk
Erythromycin Pledgets USP
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class II · Moderate risk
Compounded Plaquex
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
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 II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: One lot exceeded the mechanical peel specification
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.
Class II · Moderate risk
Magnesium sulfate various strengths in sodium chloride
Lack of sterility assurance.
Class II · Moderate risk
Ranitidine various strengths in syringes
Lack of sterility assurance.
Class II · Moderate risk
Thiamine 100 mg/ ml vials
Lack of sterility assurance.
Class II · Moderate risk
Folic acid 1 mg/ 0.2 ml pre-drawn syringes
Lack of sterility assurance.
Class II · Moderate risk
Dopamine various strengths in dextrose
Lack of sterility assurance.
Class II · Moderate risk
Dobutamine various strengths in dextrose
Lack of sterility assurance.
Class II · Moderate risk
Caspofungin various strengths in normal saline
Lack of sterility assurance.