Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
FDA Drug Recalls
354 recalls, newest first
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
hyalogic For Dry Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Red Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Pink Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Aging Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Floaters Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye strain Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Dryness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye Twitching Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Blur Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Allergy Eyes Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Methylprednisolone acetate Injectable Suspension
Failed Dissolution Specifications
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk
Clindamycin Phosphate
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin 5mg/ml
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin PF
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Broncochem Cold & Tea
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
Broncochem Cold & Flu Syrup Kids
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 I · High risk
Methocarbamol Injection
Presence of Particulate Matter
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.