Class II · Moderate risk Terminated
Compounded Plaquex
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
KETOROLAC Tromethamine Inj.
Reason Crystallization
Class II · Moderate risk Terminated
KETOROLAC Tromethamine Inj.
Reason Crystallization
Class II · Moderate risk Terminated
Ketorolac Tromethamine Ophthalmic Solution
Reason Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class II · Moderate risk Terminated
Levetiracetam
Reason Failed Dissolution Specifications: 6 month time point.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: One lot exceeded the mechanical peel specification
Class II · Moderate risk Terminated
Benzonatate Capsules
Reason Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Class II · Moderate risk Terminated
Glycopyrrolate injection
Reason 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 Terminated
Virazole
Reason 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 Terminated
Children's Loratadine Syrup
Reason Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk Terminated
Total parenteral nutrition various strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
L-cysteine various strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Immune globulin g human various strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Diphenhydramine 50 mg/ml vials
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dehydrated alcohol vials
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium sulfate various strengths in sodium chloride
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ranitidine various strengths in syringes
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Thiamine 100 mg/ ml vials
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Folic acid 1 mg/ 0.2 ml pre-drawn syringes
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dopamine various strengths in dextrose
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dobutamine various strengths in dextrose
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Caspofungin various strengths in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Milrinone various strengths in dextrose
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Acyclovir various strengths in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Tigecycline various strengths in normal saline
Reason Lack of sterility assurance.