Class II · Moderate risk
TRP Natural Eyes Dryness Relief
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
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
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
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
PROBLEND Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven Hand Sanitizer Gel
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven FOR GAS ISLAND USE ONLY
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND E3 Foaming Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class I · High risk
ForeverMen Natural Energy Boost Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.