Class II · Moderate risk Ongoing
TRP Natural Eyes Aging Eye Relief
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
TRP Natural Eyes Floaters Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye strain Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Dryness Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye Twitching Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Blur Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Allergy Eyes Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk Ongoing
Methylprednisolone acetate Injectable Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Lidocaine HCL 1%
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin 5mg/ml
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin PF
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Broncochem Cold & Tea
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Ongoing
Broncochem Cold & Flu Syrup Kids
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk Ongoing
Clobazam Tablets 10mg
Reason CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk Ongoing
Terlivaz
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk Ongoing
Acthar Gel
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk Ongoing
Mesalamine Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Ongoing
Lubricant PM Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CVS Health Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Equate Stye Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Equate Lubricant Eye Ointment
Reason Lack of Assurance of Sterility